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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 61–80 of 1,000 recalls

Class IITerminated

Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7134-70

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Failed Impurity/Degradation Specifications

November 7, 2024 · DrugView details →

Class IITerminated

Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7135-72

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Failed Impurity/Degradation Specifications

November 7, 2024 · DrugView details →

Class IITerminated

BEVACIZUMAB (AVASTIN)1.25mg/0.05mL, Sterile Injection, 0.5 mL Single-Dose Syringe, Rx Only, Repackaged by: Medivant Healthcare: 24416 N 19th Ave, Phoenix, AZ, NDC 81483-0041-1

Tailstorm Health INC

Lack of Sterility Assurance

November 6, 2024 · DrugView details →

Class IITerminated

Cooling Menthol Extra Strength Pain Relief Patch, Menthol 7.5%, packaged in box of 5, Distributed by J.R. Watkins LLC, Oakland CA 94612 UPC 8 56294 00878 5, NDC 72342-100-05

JR Watkins

cGMP Deviations

November 1, 2024 · DrugView details →

Class IITerminated

Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC: 0527-4661-37

Lannett Company Inc.

Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.

October 25, 2024 · DrugView details →

Class IITerminated

THERACARE Cold Hot Medicated Patch, Menthol 5%, 5 patches per box, Manufactured for: Veridian Healthcare, LLC, Gurnee, IL 60031 NDC 71101-954-05, UPC 8 45717 00818 1

Unexo Life Sciences Private Limited

cGMP Deviations

October 24, 2024 · DrugView details →

Class IITerminated

ABSORBINE jr. Extra Large BACK PATCH, Menthol 5%, 1 extra large patch per box, Distributed By: Absorbine Jr., LLC, Chattanooga, TN 37402 UPC 8 89476 41218 6, UPC 8 89476 41236 0

Unexo Life Sciences Private Limited

cGMP Deviations

October 24, 2024 · DrugView details →

Class IITerminated

PARCHE LEON PAIN RELIEVING HOT PATCH, Camphor 3%, Menthol 1.25%, Capsaicin 0.025%, 6 patches per box, Distributed by: Pharmadel LLC, Georgetown, DE 19947 NDC 55758-039-01, UPC 8 59424 00433 6

Unexo Life Sciences Private Limited

cGMP Deviations

October 24, 2024 · DrugView details →

Class IITerminated

THERACARE MAXIMUM STRENGTH PAIN RELIEF 4% LIDOCAINE PATCH, a) 1 patch (NDC 71101-001-24, UPC 8 45717 00878 5) and b) 6 patches (NDC 71101-001-06, UPC 8 45717 01056 6), Manufactured for: Veridian Healthcare, LLC, Gurnee, IL 60031

Unexo Life Sciences Private Limited

cGMP Deviations

October 24, 2024 · DrugView details →

Class IITerminated

LILAS Feminine Pain Relief Patch, Menthol 10%, a) 5 patches per box (UPC 7 87099 48212 1) and 10 patches per box (UPC 7 87099 48211 4), Distributed by: Lilas Wellness, Inc., Beaverton, Oregon 97008-7105

Unexo Life Sciences Private Limited

cGMP Deviations

October 24, 2024 · DrugView details →

Class IITerminated

EQUATE MAXIMUM STRENGTH LIDOCAINE PAIN RELIEVING PATCH Lidocaine 4% Topical Anesthetic, 6 patches per box PATCHES, LIDOCAINE 4%, Distributed by: Walmart Inc., Bentonville, AR 72716 NDC 79903-106-06

Unexo Life Sciences Private Limited

cGMP Deviations

October 24, 2024 · DrugView details →

Class IITerminated

JR WATKINS COOLING PAIN RELIEF PATCHES, Menthol 7.5%, 5 patches per box, Distributed By: J.R. Watkins, LLC, Oakland, CA 94612 UPC 8 56294 00878 5

Unexo Life Sciences Private Limited

cGMP Deviations

October 24, 2024 · DrugView details →

Class IITerminated

ABSORBINE jr ULTRA STRENGTH PAIN PATCH, Menthol 6.5%, 1 patch per box, Distributed By: Absorbine Jr. LLC, Chattanooga, TN 37402 UPC 8 89476 41318 3, UPC 8 89476 41336 7

Unexo Life Sciences Private Limited

cGMP Deviations

October 24, 2024 · DrugView details →

Class IITerminated

CHEEKY BONSAI PAIN RELIEF PATCHES, Menthol 10%, 4 patches per box, Distributed by Cheeky Bonsai, San Francisco, CA UPC 8 60006 57564 9

Unexo Life Sciences Private Limited

cGMP Deviations

October 24, 2024 · DrugView details →

Class IITerminated

ABSORBINE JR PAIN RELIEVING KNEE PATCH, Camphor 7%, Menthol 7%, packaged in a) 1 patch (UPC 8 89476 41251 3) and b) 6 patches (UPC 8 89476 41306 0), Distributed By: Absorbine Jr., LLC, Chattanooga, TN 37402

Unexo Life Sciences Private Limited

cGMP Deviations

October 24, 2024 · DrugView details →

Class IITerminated

HealthWise PERIOD PATCH Menstrual Pain Relief, Menthol 10%, 10 patches per box, Manufactured for Veridian Healthcare, LLC, Gurnee, IL 60031 NDC 71101-947-10, UPC 8 45717 01072 6

Unexo Life Sciences Private Limited

cGMP Deviations

October 24, 2024 · DrugView details →

Class IITerminated

Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68180-591-01), and c) 500 count (NDC 68180-591-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India

Lupin Pharmaceuticals Inc.

CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor

October 23, 2024 · DrugView details →

Class IITerminated

Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count NDC 68180-589-01), and c) 500 count (NDC 68180-589-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India

Lupin Pharmaceuticals Inc.

CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor

October 23, 2024 · DrugView details →

Class IITerminated

Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 500 count (NDC 68180-590-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India

Lupin Pharmaceuticals Inc.

CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor

October 23, 2024 · DrugView details →

Class IITerminated

Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24

BLI International, Inc.

Superpotent Drug: Stability failure for assay at 6 months test time-point.

October 21, 2024 · DrugView details →

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