Prescription medicine recalls

Prescription medicine · American Regent, Inc.

American Regent, Inc. — Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, American Regent, Inc. Shirley, NY 11967, NDC: 0517-2340-01 (vial), NDC: 0517

Presence of Particulate Matter: Potential for glass delamination from the vials.

Prescription medicine · Safecor Health, LLC · 587 boxes affected

Safecor Health, LLC — Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-101-01

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

Prescription medicine · American Regent, Inc.

American Regent, Inc. — Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only

Presence of Particulate Matter: Potential for glass delamination from the vials.

Prescription medicine · Safecor Health, LLC · 791 boxes affected

Safecor Health, LLC — Calcium Carbonate Chewable 500 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-106-01

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

Food & drug recall · FDANovember 8, 2024Serious

ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only

Prescription medicine · ACCORD HEALTHCARE, INC.

Subpotent drug

Prescription medicine · Aurobindo Pharma USA Inc

Aurobindo Pharma USA Inc — Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05), Rx Only

cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Prescription medicine · The Harvard Drug Group LLC dba Major… · N/A affected

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7135-72

Failed Impurity/Degradation Specifications

Prescription medicine · Aurobindo Pharma USA Inc · 102576 bottles affected

Aurobindo Pharma USA Inc — Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-831-05), Rx Only

cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Prescription medicine · Aurobindo Pharma USA Inc · 3336 bottles affected

Aurobindo Pharma USA Inc — Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-832-05), Rx Only

cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Prescription medicine · The Harvard Drug Group LLC dba Major… · N/A affected

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7134-70

Failed Impurity/Degradation Specifications

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

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

Midlab Incorporated — Compliance Dishwashing Liquid & Antibacterial Soap, PCMX 0.1%, Net Contents: 1 Gallon, 128 Ounces, 3.785 Liters, Royal Corporation, 10232 Palm Drive, Santa Fe Springs, CA 90670

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

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 — 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 — 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