The Compounding Pharmacy of America

383 recalls •

💊 Drugs

• Categories: Prescription Drugs, Compounded Drugs

HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection 5 mL, Multi-Dose Vial, Sterile, Rx Only, Compounded by The Compounding Pharmacy of America, 6216 Highland Place Way, Ste. 101A Knoxville, TN 37919 Ph (855) 277-2488 Fax (888) 689-9892

Class I - Dangerous

Non-Sterility

Jan 12, 2018 Prescription Drugs View Details →

HCG 1,100 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Prescription Drugs Nationwide View Details →

Testosterone 20 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

HCG 1,250 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Prescription Drugs Nationwide View Details →

Hydromorphone 30 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Morphine 60 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Hyaluronic Acid Sodium 28 mg/ml + Lidocaine HCl 3 mg/ml Injection, ml Syringe, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Prescription Drugs Nationwide View Details →

Hydromorphone 50 mg/ml + Fentanyl 3,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Hydromorphone 80 mg/ml + Bupivacaine 10 mg/ml + Clonidine 1,000 mcg/ml, Baclofen 500 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Fentanyl 2,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Morphine 25 mg/ml + Bupivacaine 30 mg/ml + Clonidine 200 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Testosterone 12.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Hydromorphone 80 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml + Baclofen 750 mcg/ml Intrathecal Solution, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Tri-Mix AT-6 (60 mg/4 mg/0.3 mg) Injectable, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

B-Complex 100 mg/ml Injection, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Prescription Drugs Nationwide View Details →

PGE 2 (Alprostadil) 100 mcg/ml, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Morphine 25 mg/ml + Bupivacaine 20 mg/ml + Clonidine 2,000 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Morphine 12.5 mg/ml Solution, Sterile-Preservative Free,The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Quad-Mix 4 Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Phosphatidylcholine 0.1% Sodium Deoxycholate 0.089% Injection, Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Prescription Drugs Nationwide View Details →

L-Arginine 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Hydromorphone 20 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Morphine 50 mg/ml + Clonidine 200 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Mitomycin 40 mg/50 ml Sodium Chloride 0.9% Injection, Single Dose Syringe, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Prescription Drugs Nationwide View Details →

Acetylcysteine 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

HCG 1,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 23 DAY KIT, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Prescription Drugs Nationwide View Details →

Tri-Mix (17.7 mg/0.59 mg/6 mcg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Baclofen 2,500 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Tri-Mix (6.9/0.575/39.375) Injectable, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Tri-Mix Super Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Estradiol 25 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Lipovicine Modified II Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Tri-Mix MEDIUM (15 mg/0.5 mg/5 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Estradiol 8 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Tri-Mix (37.5 mg/1.5 mg/50 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Fentanyl 17,500 mcg/ml + Clonidine 1,000 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Tri-Mix T-106/PGE 2 0.1/0.14 Injectable, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 50 mg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Morphine 50 mg/ml + Fentanyl 1,500 mcg/ml + Baclofen 800 mcg/ml +Clonidine 200 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Morphine 50 mg/ml + Fentanyl 3,000 mcg/ml + Baclofen 450 mcg/ml, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Tri-Mix ST3/PGE 2/LIDO 2 0.06/0.2/0.02 Injectable, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Tri-Mix T-50 8.8 mg/0.29 mg/2.9 mcg Injectable, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Sufentanil 50 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Lipotropic (w/Cyanocobalamin 4000 mcg/ml) Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Prescription Drugs Nationwide View Details →

Tri-Mix (30/0.5/10) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

MIC+Methylcobalamin 4000 mcg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Prescription Drugs Nationwide View Details →

Magnesium Sulfate 500 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Hydroxocobalamin 1,000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Prescription Drugs Nationwide View Details →

LIPO-VITE III, Injection Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Prescription Drugs Nationwide View Details →

Hydromorphone 10 mg/ml + Baclofen 2,500 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

TRI-MIX (1/1/40) (MFG) Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Cyanocobalamin 1,000 mcg/ml, Multi-Dose vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Tri-Mix (37.5/2/20) Injectable, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

B-Complex Injection, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Prescription Drugs Nationwide View Details →

Lidocaine 1% Injection, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Prescription Drugs Nationwide View Details →

Tri-Mix (30/1/22) (MFG) Injectable, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Testosterone 37.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Fentanyl 5,000 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Fentanyl 950 mcg/ml + Bupivacaine 5 mg/ml Intrathecal Solution, Sterile-Preservative Free,The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

5-Methy Tetrahydrofolate 5 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

HCG 2,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Prescription Drugs Nationwide View Details →

Neomycin + Polymyxin B+ Bacitracin Ophthalmic Ointment, grams, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Methylcobalamin 1,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Hyaluronidase 150 units/ml Injection, ml, Sterile, Preserved, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Prescription Drugs Nationwide View Details →

Zinc 5 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

HCG 625 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Prescription Drugs Nationwide View Details →

Cholecalciferol 600,000 IU/ml Injectable, ml Vial, Sterile, Refrigerate, The Compounding Pharmac of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Tri-Mix (15 mg/0.5 mg/20 mcg) Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

MYO-DEN (30 ml) 25 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Prescription Drugs Nationwide View Details →

Testosterone 80 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Acetyl-L-Carnitine 500 mg/ml, Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Hydromorphone 80 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml Intrathecal Solution, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Tri-Mix T-105 (30 mg/1 mg/10 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Tri-Mix (18 mg/0.6 mg/5.88 mcg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

HCG 5,000 IU/ml + Methylcobalamin 1,000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Prescription Drugs Nationwide View Details →

Hyaluronidase 150 units/ml Injection, ml, Sterile, Preservative Free, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Prescription Drugs Nationwide View Details →

HCG 10,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Prescription Drugs Nationwide View Details →

Tri-Mix (25/2.5/10) (MFG) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Testosterone 75 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Testosterone Bi-Blend 50 mg/ml + Estradiol Valerate 2.5 mg/ml Injectable, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Morphine 30 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Fentanyl 7,500 mcg/ml, + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Tri-Mix (25/2.5/10) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Sermorelin/GHRP6 1000/1000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Prescription Drugs Nationwide View Details →

Folic Acid 5 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Prescription Drugs Nationwide View Details →

Sermorelin 300 mcg/ml + GHRP-2 300 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Prescription Drugs Nationwide View Details →

LIPO-EXTREME Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Nandrolone Decanoate 200 mg/ml Injection, ml Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Prescription Drugs Nationwide View Details →

Oxytocin 100 units/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Prescription Drugs Nationwide View Details →

Sermorelin/GHRP2 1000/1000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Prescription Drugs Nationwide View Details →

Morphine 30 mg/ml + Clonidine 250 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Fentanyl 1,000 mcg/ml Intrathecal Solution, Sterile-Preservative Free,The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Buckshot Injectable, Multi-Dose, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Morphine 30 mg/ml + Bupivacaine 5 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Morphine 50 mg/ml + Fentanyl 3,000 mcg/ml + Bupivacaine 15 mg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

LIPO-Tropic Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Tri-Mix (17.7/0.59/6) (MFG) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Hydroxocobalamin 10 mg/ml Folic Acid 4 mg/ml Injectable, ml Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Tri-Mix ST4/PGE 2/LIDO 2 0.1/0.05/0.05 Injectable, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →

Morphine 25 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Jun 2, 2015 Compounded Drugs Nationwide View Details →