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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 8261–8280 of 17,773 recalls

Class IITerminated

GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00

H J Harkins Company Inc dba Pharma Pac

Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.

October 18, 2018 · DrugView details →

Class IIITerminated

Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Palm Harbor, FL 34684

Promise Pharmacy LLC

Presence of precipitate

October 18, 2018 · DrugView details →

Class IITerminated

Testosterone 25 mg pellet, 1 count (NDC: 69761-125-01) and 30 count vials (NDC: 69761-125-30), Rx Only Qualgen, LLC, Edmond, OK 73013

Qualgen, LLC

Lack of Assurance of Sterility

October 17, 2018 · DrugView details →

Class IITerminated

Testosterone 50mg pellet, 1 count (NDC 69761-150-01), 6 count (NDC 69761-150-06), 12 count (NDC 69761-150-12), and 30 count (NDC 69761-150-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013

Qualgen, LLC

Lack of Assurance of Sterility

October 17, 2018 · DrugView details →

Class IITerminated

Estradiol 15mg pellet, 1 count (NDC 69761-015-01), 6 count (NDC 69761-015-06), 12 count (NDC 69761-015-12), and 30 count (NDC 69761-015-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013

Qualgen, LLC

Lack of Assurance of Sterility

October 17, 2018 · DrugView details →

Class IITerminated

Estradiol 12.5mg pellet, 1 count (NDC 69761-012-01), 6 count (NDC 69761-012-06), 12 count (NDC 69761-012-12), and 30 count (NDC 69761-012-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013

Qualgen, LLC

Lack of Assurance of Sterility

October 17, 2018 · DrugView details →

Class IITerminated

Testosterone 100mg pellet, 1 count (NDC 69761-110-01), 6 count (NDC 69761-110-06), 12 count (NDC 69761-110-12), and 30 count (NDC 69761-110-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013

Qualgen, LLC

Lack of Assurance of Sterility

October 17, 2018 · DrugView details →

Class IITerminated

Testosterone 200 mg/Anastrozole 20 mg pellet, 1 count (NDC 69761-222-01), 6 count (NDC 69761-222-06), 12 count (NDC 69761-222-12), and 30 count (NDC 69761-222-30) vials, Rx Only, Qualgen, Edmond, OK 73013

Qualgen, LLC

Lack of Assurance of Sterility

October 17, 2018 · DrugView details →

Class IITerminated

Estradiol 18mg pellet, 1 count (NDC 69761-018-01), 6 count (NDC 69761-018-06), 12 count (NDC 69761-018-12), and 30 count (NDC 69761-018-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013

Qualgen, LLC

Lack of Assurance of Sterility

October 17, 2018 · DrugView details →

Class IITerminated

Testosterone 37.5 mg pellet, 1 count (NDC 69761-137-01), 6 count (NDC 69761-137-06), 12 count (NDC 69761-137-12) and 30 count (NDC 69761-137-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013

Qualgen, LLC

Lack of Assurance of Sterility

October 17, 2018 · DrugView details →

Class IITerminated

Testosterone 200mg pellet, 1 count (NDC 69761-120-01), 6 count (NDC 69761-120-06), 12 count (NDC 69761-120-12), and 30 count (NDC 69761-120-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013

Qualgen, LLC

Lack of Assurance of Sterility

October 17, 2018 · DrugView details →

Class IITerminated

Testosterone 87.5mg pellet, 1 count (NDC 69761-187-01), 6 count (NDC 69761-187-06), 12 count (NDC 69761-187-12), and 30 count (NDC 69761-187-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013

Qualgen, LLC

Lack of Assurance of Sterility

October 17, 2018 · DrugView details →

Class IITerminated

Estradiol 25mg pellet, 1 count (NDC 69761-025-01), 6 count (NDC 69761-025-06), 12 count (NDC 69761-025-12), and 30 count (NDC 69761-025-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013

Qualgen, LLC

Lack of Assurance of Sterility

October 17, 2018 · DrugView details →

Class IITerminated

Testosterone 12.5mg pellet, 1 count (NDC 69761-112-01), 6 count (NDC 69761-112-06), 12 count (NDC 69761-112-12), and 30 count (NDC 69761-112-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013

Qualgen, LLC

Lack of Assurance of Sterility

October 17, 2018 · DrugView details →

Class IITerminated

Estradiol 6 mg pellet, 1 count (NDC 69761-006-01), 6 count (NDC 69761-006-06), 12 count (NDC 69761-006-12), and 30 count (NDC 69761-006-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013

Qualgen, LLC

Lack of Assurance of Sterility

October 17, 2018 · DrugView details →

Class IITerminated

Estradiol 10mg pellet, 1 count (NDC 69761-010-01), 6 count (NDC 69761-010-06), 12 count (NDC 69761-010-12), and 30 count (NDC 69761-010-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013

Qualgen, LLC

Lack of Assurance of Sterility

October 17, 2018 · DrugView details →

Class IITerminated

Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only, Mfg. By Emcure Pharmaceutical Ltd Hinjawadi, Pune, India, Mfg for: Heritage Pharmaceuticals Inc. UPC 323155216388, NDC 23155-216-31

Heritage Pharmaceuticals, Inc.

Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle

October 15, 2018 · DrugView details →

Class IITerminated

Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme Registro Sanitario No SD2014-0002208 LLC-USA

Zero Xtreme USA

Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine

October 15, 2018 · DrugView details →

Class IIITerminated

Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile single use glass vial, Rx Only, Manufactured for: Claris Lifesciences, Inc., North Brunswick, NJ 08902. By: Claris Injectables Ltd., Gujarat, India. NDC: 36000-033-10

Baxter Healthcare Corporation

Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.

October 15, 2018 · DrugView details →

Class IITerminated

HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg per 5 mL, Rx only, Distributed by Lannett Company, Inc., Philadelphia, PA 19154, NDC 54838-502-80.

Lannett Company, Inc.

CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.

October 11, 2018 · DrugView details →

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