Prescription medicine recalls

Midlab Incorporated — boardwalk ANTIBACTERIAL HANDSOAP REFILL, Chloroxylenol 0.1%, 1 gal. (3.78 L)

cGMP Deviations: Out of specification results for micro in hand soap products.

Prescription medicine · Tailstorm Health INC · 27,560 Syringes affected

Tailstorm Health INC — 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

Lack of Sterility Assurance

Midlab Incorporated — ROYALAB Germ Away Antibacterial Hand Soap, Chloroxylenol 0.1%, NET CONTENTS: ONE U.S. GALLON (3.78 L), Royal Papers, 2701 Hereford St., St. Louis, MO 63139

cGMP Deviations: Out of specification results for micro in hand soap products.

Midlab Incorporated — MAXIM Assure Antibacterial, Chloroxylenol 0.1%, Net Contents: One U.S. Gallon (3.78 L), For Industrial and Institutional Use Only, MIDLAB 140 Private Brand Way, Athens, TN 37303

cGMP Deviations: Out of specification results for micro in hand soap products.

Midlab Incorporated — Array Liquid Antiseptic Handwash, Chloroxylenol 0.1%, NET CONTENTS: 128 FL OZ (1 GAL) 3.785 L, FOR DISTRIBUTION EXCLUSIVELY BY GORDON FOOD SERVICE, WYOMING, MI 49509

Food & drug recall · FDANovember 5, 2024Labelling issue

cGMP Deviations: Out of specification results for micro in hand soap products.

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton

Prescription medicine · The Harvard Drug Group LLC dba Major… · 25814 tablets affected

Failed Impurities/Degradation Specifications; during routine stability testing for impurities.

Prescription medicine · Glenmark Pharmaceuticals Inc., USA · 5232 bottles affected

Glenmark Pharmaceuticals Inc., USA — Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pitha

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.

Prescription medicine · Glenmark Pharmaceuticals Inc., USA · 34848 bottles affected

Glenmark Pharmaceuticals Inc., USA — Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.

Prescription medicine · Glenmark Pharmaceuticals Inc., USA · 4704 bottles affected

Glenmark Pharmaceuticals Inc., USA — Diltiazem Hydrochloride Extended-Release Capsules, USP 90mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pitham

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.

Prescription medicine · JR Watkins · 7,138 patches affected

JR Watkins — Cooling Menthol Extra Strength Pain Relief Patch, Menthol 7.5%, packaged in box of 5

cGMP Deviations

Prescription medicine · Glenmark Pharmaceuticals Inc., USA · 7296 bottles affected

Glenmark Pharmaceuticals Inc., USA — Diltiazem Hydrochloride Extended-Release Capsules, USP 120mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pitha

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.

Prescription medicine · Glenmark Pharmaceuticals Inc., USA · 12,864 bottles affected

Glenmark Pharmaceuticals Inc., USA — Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg, Rx Only, 100 Capsules

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.