cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Prescription Drugs
💊 Drugs • 12,141 recalls
Lorazepam 1 mg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Family Pharmacy of Statesville
Lack of Assurance of Sterility
Trimix (Alprostadil/Papaverine/Phentolamine) 10 mcg/20 mg/1 mg Injectable 5 mL vials, Rx only, Family Pharmacy of Statesville, Inc.
Family Pharmacy of Statesville
Lack of Assurance of Sterility
Methylcobalamin 1 mg/mL Injectable in 1 mL syringes, Rx only, Family Pharmacy of Statesville, Inc.
Family Pharmacy of Statesville
Lack of Assurance of Sterility
Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Family Pharmacy of Statesville
Lack of Assurance of Sterility
Alprazolam Tablets, USP 1mg, 180-count bottles, Rx only, Manufactured by ULTRAlab Laboratories, Inc., NY; Packaged by GSMS, Inc., CA NDC 60429-504-18.
Golden State Medical Supply
CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing process.
Morphine Sulfate 6 mg/mL Infusion in 250 mL bag, Rx only, Family Pharmacy of Statesville, Inc.
Family Pharmacy of Statesville
Lack of Assurance of Sterility
Ketamine 50 mg Infusion (LV 1) Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Family Pharmacy of Statesville
Lack of Assurance of Sterility
Hydromorphone HCl 2 mg/mL Infusion 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Family Pharmacy of Statesville
Lack of Assurance of Sterility
0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC 0264-7800-20
B. Braun Medical
Lack of sterility assurance: leaking bags
Hydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Family Pharmacy of Statesville
Lack of Assurance of Sterility
Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Family Pharmacy of Statesville
Lack of Assurance of Sterility
Avaphinal Maximum Male Enhancement Sexual Pills, 2000 MG*, packaged in 10 Capsules per carton.
Walmart Stores
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Vancomycin14 mg/mL Fortified Ophthalmic Solution in 5 mL bottles, Rx only, Family Pharmacy of Statesville, Inc.
Family Pharmacy of Statesville
Lack of Assurance of Sterility
Trimix (Alprostadil/Papaverine/Phentolamine) 20 mcg/30 mg/0.5 mg Injectable 5 mL vials, Rx only, Family Pharmacy of Statesville, Inc.
Family Pharmacy of Statesville
Lack of Assurance of Sterility
hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152 USA. NDC # 0904-6440-61
The Harvard Drug Group
Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
Hydromorphone HCl 1 mg/mL 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Family Pharmacy of Statesville
Lack of Assurance of Sterility
CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
Impurity failure at 0-time of the repackaged lot.
Failed Dissolution Specifications