FDA Recalls

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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 121–140 of 1,000 recalls

Class ITerminated

REVITADERM WOUND CARE GEL, (Benzalkonium Chloride in a gel containing transforming growth factor-b), 0.1%, packaged in 29.6 mL (1.0 FL OZ) bottles (NDC 63347-120-02) and 88.7 mL (3.0 FL OZ) tubes (NDC 63347-120-01), Blaine Labs Inc., Santa Fe Springs, CA 90670

Blaine Labs Inc

Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.

January 25, 2022 · DrugView details →

Class ITerminated

Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502-0196-71), packaged in Five 3 mL Prefilled Pens per carton (NDC 49502-0196-75), Rx only, Manufactured in Malaysia for: Mylan Specialty L.P., Morgantown, WV, 26505.

Mylan Pharmaceuticals Inc

Labeling: Missing Label: label missing from some Semglee prefilled pens.

January 5, 2022 · DrugView details →

Class ITerminated

SENNA Syrup (sennosides) 8.8 mg/ 5 mL unit-dose cups, packaged in 24 cups per carton, Mfg for: AvKARE, TN 38478, NDC 50262-731-24.

Lohxa, LLC

Microbial Contamination of Non-Sterile Product

December 21, 2021 · DrugView details →

Class ITerminated

Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC 51672-1259-3

Taro Pharmaceuticals U.S.A., Inc.

Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria

December 15, 2021 · DrugView details →

Class ITerminated

kleantouch HAND SANITIZER (ethyl alcohol 70%), 8.0 FL OZ (236 ML), pump bottles, Distributed by: Valisa MFG, LLC, Farmingdale, NY, 11735, Made in USA, UPC 6 86162 99246 1

Valisa MFG LLC

Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol

December 6, 2021 · DrugView details →

Class ITerminated

Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, NDC 61958-2901-2

Gilead Sciences, Inc.

Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates.

December 3, 2021 · DrugView details →

Class ITerminated

Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) Ingredients Ethanol and Methanol, in 55-gallon drums, Aroma Release Technology, Inc., 7026 Discovery Drive, Chattanooga, TN 37416

Aroma Release Technologies Inc

Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol

November 30, 2021 · DrugView details →

Class ITerminated