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Prescription Drugs

💊 Drugs • 12,141 recalls

Cleocin Phosphate, clindamycin injection, USP, 900 mg/ 6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017. NDC 0009-3447-01

Pfizer

Class I - Dangerous

Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point

Mar 15, 2019 Prescription Drugs Nationwide View Details →

NORepinephrine 16 mg added to 0.9% Sodium Chloride (PF), 16 mg / 250 mL, 250 mL IV bag, Rx only, KRS Global Biotechnology: 791 Park of Commerce Blvd., Boca Raton, FL 33487. NDC 3321678343

KRS Global Biotechnology

Class I - Dangerous

Labeling: Label mix-up

Jan 16, 2019 Prescription Drugs Nationwide View Details →

8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL) 50 mL Single-dose fliptop vial, 25 vials per carton, Rx only Hospira, Inc. Lake Forest, IL 60045 USA ---- NDC 0409-6625-02

Pfizer

Class I - Dangerous

Presence of Particulate Matter; glass particulates

Mar 15, 2019 Prescription Drugs View Details →

Clindamycin Injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA, NDC 47781-620-94

Pfizer

Class I - Dangerous

Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point

Mar 15, 2019 Prescription Drugs Nationwide View Details →

Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati, OH 45202, Manufactured for: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-494-54

Legacy Pharmaceutical Packaging

Class I - Dangerous

CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected.

Mar 1, 2019 Prescription Drugs View Details →

Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx only, HI-TECH Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-587-16

Akorn

Class I - Dangerous

Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.

Mar 28, 2019 Prescription Drugs View Details →

NORepinephrine 4 mg added to 5% Dextrose 250 mL Bag (PF), 4 mg / 250 mL, 250 mL IV bag, Rx only, KRS Global Biotechnology: 791 Park of Commerce Blvd., Boca Raton, FL 33487. NDC 3321674481

KRS Global Biotechnology

Class I - Dangerous

Labeling: Label mix-up

Jan 16, 2019 Prescription Drugs Nationwide View Details →

Clindamycin Injection, USP, 900 mg/6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA. NDC 47781-621-94

Pfizer

Class I - Dangerous

Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point

Mar 15, 2019 Prescription Drugs Nationwide View Details →

Clindamycin Injection, USP, 300 mg/ 2 mL (150 mg/mL), 2 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA.,NDC 47781-619-94

Pfizer

Class I - Dangerous

Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point

Mar 15, 2019 Prescription Drugs Nationwide View Details →

Cleocin Phosphate, clindamycin injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017, NDC 0009-3124-01

Pfizer

Class I - Dangerous

Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point

Mar 15, 2019 Prescription Drugs Nationwide View Details →

Cleocin Phosphate (clindamycin injection), USP, 300 mg/ 2 mL (150 mg/mL), 2 mL-vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017, NDC 0009-6582-02

Pfizer

Class I - Dangerous

Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point

Mar 15, 2019 Prescription Drugs Nationwide View Details →

Cefuroxime 10mg/mL INJ 0.5 mg, SDV, Rx only, Pacific Compounding, Stockton, CA

Pacific Compounding Pharmacy & Consultations

Class I - Dangerous

Presence of Particulate Matter: Particulate matter was reported in one lot of Cefuroxime by a physician after use of product.. FDA analysis identified the particulate as coring of the rubber stopper

Aug 23, 2018 Prescription Drugs View Details →

Fayosim (levonorgestrel and ethinyl estradiol) tablets USP, (0.15 mg/0.02 mg, 0.15 mg/0.025 mg, 0.15 mg/0.03 mg) and ethinyl estradiol tablets USP, (0.01 mg), packaged in 1 Extended-Cycle Wallet of 91 Tablets packed in a pouch(NDC 68180-860-11); one pouch per carton (NDC 68180-860-12), Rx only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA.

Lupin Pharmaceuticals

Class I - Dangerous

Failed Impurities/Degradation Specifications: Out-of-specification results observed in related substance test (Any Other Individual Impurity and Total impurities) in Ethinyl Estradiol Tablets USP 0.01mg at 12 month long term stability study.

Mar 22, 2019 Prescription Drugs Nationwide View Details →

Blue Fusion Capsules, 1- count blister pack, Distributed by: DNS Distribution 5225 Canyon Crest Dr. Ste 71-640, Riverside, CA 92507, UPC 7 48252 66460 0

Ata International

Class I - Dangerous

Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared ingredients: Sildenafil, Tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin, and daidzein.

Mar 14, 2019 Prescription Drugs Nationwide View Details →

Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408, NDC 50742-308-05.

Ingenus Pharmaceuticals

Class I - Dangerous

Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.

Mar 18, 2019 Prescription Drugs Nationwide View Details →

Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% 5 mL bottles, Rx only, Allergan, Inc. Irvine, CA 92612 U.S.A. NDC 0023-9211-05

Allergan Sales

Class I - Dangerous

cGMP Deviations

Mar 19, 2019 Prescription Drugs View Details →

Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC 68180-943-11

Lupin Pharmaceuticals

Class I - Dangerous

Defective Container: Repetitive complaints received indicating pump not working.

Mar 13, 2019 Prescription Drugs View Details →

Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY; By: Iso-Tex Diagnostics, Inc.; NDC 50914-7720-8.

Iso-Tex Diagnostics

Class I - Dangerous

Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.

Mar 11, 2019 Prescription Drugs View Details →

Losartan Potassium Tablets USP, 50 mg, Rx only, a) 30 count (NDC 31722-701-30), b) 90 count (NDC 31722-701-90), c) 1000 count (NDC 31722-701-10) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar -509 301, India

Camber Pharmaceuticals

Class I - Dangerous

CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient

Feb 28, 2019 Prescription Drugs Nationwide View Details →

Losartan Potassium Tablets USP, 100 mg, Rx only, a) 30 count (NDC 31722-702-30), b) 90 count (NDC 31722-702-30), c) 1000 count (NDC 31722-702-10) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar -509 301, India

Camber Pharmaceuticals

Class I - Dangerous

CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient

Feb 28, 2019 Prescription Drugs Nationwide View Details →

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