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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

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

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 5601–5620 of 17,755 recalls

Class IITerminated

Prednisone Tablets, USP 2.5 mg, 100 tablets, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, Manufactured by: Tianjin Tianyao Pharmaceuticals Co., Ltd No. 221 Huanghai Road, Tianjin Economical-Technological Development Area, Tianjin, China 300457 NDC 0527-2931-37

Lannett Company, Inc.

Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contained Prednisone Tablets, USP 10 mg

August 10, 2020 · DrugView details →
Class IITerminated

Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg Double Strength, 500 Tablets per bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC: 65862-420-05.

Aurobindo Pharma USA Inc.

Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).

August 10, 2020 · Drug
View details →
Class IITerminated

UltraCruz Hand Sanitizing Gel Antimicrobial (70% Isopropyl Alcohol), packaged in 3 Fluid Oz./89 mL bottes, Manufactured By Santa Cruz Biotechnology, Inc. 10410 Finnell St. Dallas, TX 75220

Santa Cruz Biotechnology, Inc

Subpotent drug

August 7, 2020 · DrugView details →
Class IITerminated

Just Hand Sanitizer (Ethyl Alcohol 73%) Single Use-Packs 100-count NDC 78065-2020-2 UPC 703123998598 (Single packs NDC 78065-2020-1 UPC 703123998659) Distributed by: Just Hand Sanitizer

Open Book Extracts

Labeling Not Elsewhere Classified: Product labeled to contain methanol

August 7, 2020 · DrugView details →
Class IITerminated

Always Be Clean Hand Sanitizer (73% Alcohol) 0.04 FL OZ (1.2 mL) packaged in a) Single snaps (NDC 75091-2020-1 UPC 375091202016); b) 100-count boxes (NDC 75091-2020-2 UPC 375091202023); c) 25-count boxes (NDC 75091-2020-3 UPC 375091202030)

Open Book Extracts

Labeling Not Elsewhere Classified: Product labeled to contain methanol

August 7, 2020 · DrugView details →
Class IITerminated

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

August 6, 2020 · DrugView details →
Class IITerminated

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

August 6, 2020 · DrugView details →
Class IITerminated

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

August 6, 2020 · DrugView details →
Class IITerminated

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

August 6, 2020 · DrugView details →
Class IITerminated

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

August 6, 2020 · DrugView details →
Class IITerminated

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

August 6, 2020 · DrugView details →
Class IITerminated

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

August 6, 2020 · DrugView details →
Class IITerminated

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

August 6, 2020 · DrugView details →
Class IITerminated

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

August 6, 2020 · DrugView details →
Class IITerminated

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

August 6, 2020 · DrugView details →
Class IITerminated

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

August 6, 2020 · DrugView details →
Class ITerminated

Incredible Products Gelbac T Antibacterial Hand Gel (ethyl alcohol 80%), Kills 99.9% bacteria and germs, a) 4.2 Oz./125 mL bottle, NDC: 71761-000-00, UPC: 7502278002555, Distributed by Pacific Coast Global Inc. Chula Vista, CA 91911, Made in Mexico b) 33.8 Oz./1 L, UPC: 7502278002586, Made in Mexico By Incredible Products S.A. de C.V. alle Castellanos y Tapia 921, Oblatos, 44350 Guadalajara, Jal, MX.

Incredible Products, SA de CV

Chemical Contamination: Product contains methanol as an active ingredient and is sub-potent for ethanol.

August 6, 2020 · DrugView details →
Class IITerminated

Losartan Potassium Tablets USP, 50 mg, 90 count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ by Hetero Labs, Limited, Mahabubragar, India

Hetero Labs Limited (Unit V)

Failed Tablet/Capsule Specification; complaint of bulging tablet

August 6, 2020 · DrugView details →
Class IITerminated

Hydromorphone HCl 1 mg/mL 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

Family Pharmacy of Statesville

Lack of Assurance of Sterility

August 6, 2020 · DrugView details →
Class IITerminated

Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0071-5, UPC 851722007125

Eosera, Inc.

cGMP Deviations.

August 4, 2020 · DrugView details →
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