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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 3521–3540 of 17,723 recalls

Class IIITerminated

Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326, NDC 60505-6197-2

Apotex Corp.

Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.

May 3, 2022 · DrugView details →

Class IITerminated

Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5, Pkg Size: 90, NDC: 68788-7758-09.

Preferred Pharmaceuticals, Inc.

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

May 3, 2022 · DrugView details →

Class IITerminated

Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5 mg, Pkg Size: 30, NDC: 68788-7758-03.

Preferred Pharmaceuticals, Inc.

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

May 3, 2022 · DrugView details →

Class IITerminated

Losartan HCTZ 100/25 mg, 90 count bottles NDC# 70518-2578-00 Repackaged NDC Original NDC # 68180-0217-09

RemedyRepack Inc.

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.

May 2, 2022 · DrugView details →

Class IITerminated

Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original NDC # 68180-0216-09

RemedyRepack Inc.

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.

May 2, 2022 · DrugView details →

Class IITerminated

MVASI (bevacizumab-awwb), Injection, For Intravenous Infusion After Dilution, 100 mg/4 ml, Single dose vial, Rx only, Manufactured by Amgen Inc. Thousand Oaks, CA 91320-1799, NDC 55513-0206-01

Amgen, Inc.

Defective container: loose crimp defect, potential loss of container integrity.

May 2, 2022 · DrugView details →

Class IIITerminated

Higher Education Make Out Ready Vegan Lip Balm, SPF 15, Net Wt. 0.15 oz (4.25 g) per tube, Active Ingredients: Oxtinoxate (7.5%), Oxybenzone (3%); Distributed by: Higher Education Skincare, 1.833.251.0388

Eco Lips, Inc

Mislabeling: The active ingredient list on the label does not match the product's actual ingredients Specifically, the label states Octinoxate 7.5% and Oxybenzone 3%, while the product therein is made with Octinoxate 7.5%, Octisalate 5%, Octocrylene 5%, and Avobenzone 3%.

April 29, 2022 · DrugView details →

Class IIITerminated

buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 200 mg, 60-count bottle, Rx only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 47335-738-86

SUN PHARMACEUTICAL INDUSTRIES INC

Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.

April 29, 2022 · DrugView details →

Class IIITerminated

buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 150 mg packaged in a) 60-count bottle (47335-737-86), b)100-count bottle (47335-737-88), c)500-count bottle (47335-737-13), Rx only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India

SUN PHARMACEUTICAL INDUSTRIES INC

Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.

April 29, 2022 · DrugView details →

Class IITerminated

alprazolam XR extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-0068-1.

Viatris Inc

Failed Dissolution Specifications: low out-of-specification dissolution test results observed.

April 28, 2022 · DrugView details →

Class IITerminated

Xanax XR (alprazolam) extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Fizer Inc, NY, NY 10017, NDC 0009-0068-07.

Viatris Inc

Failed Dissolution Specifications: low out of specification results for dissolution.

April 28, 2022 · DrugView details →

Class IIITerminated

Open Nature Cough Drops Menthol-Cough Suppressant/Oral Anesthetic Peppermint Naturally Flavored, packaged in Bags of 30 lozenges, Distributed By Lucerne Foods, Inc. P.O. Box 99, Pleasanton, CA 96566-0009, UPC 0 79893 41266 5

Bestco LLC

Subpotent drug: Low OOS for menthol content at the three month room temperature.

April 27, 2022 · DrugView details →

Class IITerminated

GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-19

Lupin Pharmaceuticals Inc.

Failed Stability Specification

April 27, 2022 · DrugView details →

Class IITerminated

Vancomycin HCl 1.5 g in 0.9% Sodium Chloride, 500 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0924-44

SCA Pharmaceuticals

CGMP Deviations

April 25, 2022 · DrugView details →

Class IITerminated

Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-078-40

SCA Pharmaceuticals

CGMP Deviations

April 25, 2022 · DrugView details →

Class IICompleted

Zonisamide Capsules, USP, 50 mg, packaged in 100-count bottles, Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-129-01

Glenmark Pharmaceuticals Inc., USA

cGMP deviations

April 25, 2022 · DrugView details →

Class IICompleted

Zonisamide Capsules USP, 25 mg, packaged in 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-128-01

Glenmark Pharmaceuticals Inc., USA

cGMP deviations

April 25, 2022 · DrugView details →

Class IICompleted

Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462-130-01); b) 500-count bottle (NDC 68462-130-05), Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430

Glenmark Pharmaceuticals Inc., USA

cGMP deviations

April 25, 2022 · DrugView details →

Class IITerminated

Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0231-32

SCA Pharmaceuticals

CGMP Deviations

April 25, 2022 · DrugView details →

Class IITerminated

Accupril (Quinapril HCl Tablets) 10 mg, 90 Tablets Rx only NDC 0071-0530-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017

Pfizer Inc.

CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.

April 22, 2022 · DrugView details →

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