Class I - Dangerous
Failed Stability Specifications
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Prescription Drugs
💊 Drugs • 12,141 recalls
Class I - Dangerous
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3650 Victorie St N, Suite 900, Shoreview, MN, NDC 71139-6030-1.
IntegraDose Compounding Services
Class I - Dangerous
Subpotent Drug
Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; (NDC 70710-1048-3).
Zydus Pharmaceuticals (USA)
Class I - Dangerous
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Class I - Dangerous
Presence of particulate matter: a white thread-like structure in the cartridge
Class I - Dangerous
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11
Amerisource Health Services
Class I - Dangerous
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-637-05
Golden State Medical Supply
Class I - Dangerous
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-638-01
Golden State Medical Supply
Class I - Dangerous
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Class I - Dangerous
Lack of Assurance of Sterility
Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11
Amerisource Health Services
Class I - Dangerous
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC 70954-531-20
ANI Pharmaceuticals
Class I - Dangerous
Defective Container; packets were found to be either empty or partially full.
Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, Made in Canada, NDC 25021-241-10.
Sagent Pharmaceuticals
Class I - Dangerous
Failed Impurities/Degradation Specifications
Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.
Lannett Company
Class I - Dangerous
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Class I - Dangerous
Presence of a Foreign Substance; black particles observed in liquid
Class I - Dangerous
Crystallization; identified as Buprenorphine free base
Class I - Dangerous
Failed Dissolution Specifications
TPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Los Angeles, 13128 Imperial Hwy, Santa Fe Spr., CA 90670
Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles
Class I - Dangerous
Incorrect Product Formulation: product did not contain insulin as listed in the label.
Class I - Dangerous
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, Made in Canada NDC 42192-619-16
Acella Pharmaceuticals
Class I - Dangerous
Chemical contamination; presence of lead and lithium above specification