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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 981–1000 of 1,000 recalls

Class IIOngoing

Vitamin B1, 100 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-108-01

Safecor Health, LLC

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

November 11, 2024 · DrugView details →

Class IIOngoing

Vitamin D3, 25 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-104-01

Safecor Health, LLC

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

November 11, 2024 · DrugView details →

Class IIOngoing

Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-449-17

ACCORD HEALTHCARE, INC.

Subpotent drug

November 8, 2024 · DrugView details →

Class IIOngoing

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, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.

Aurobindo Pharma USA Inc

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

November 7, 2024 · DrugView details →

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 IIOngoing

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, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.

Aurobindo Pharma USA Inc

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

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 IIOngoing

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, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. 90 mg - 30 Tablets - NDC 65862-833-30 90 mg - 500 Tablets - NDC 65862-833-05

Aurobindo Pharma USA Inc

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

November 7, 2024 · DrugView details →

Class IIOngoing

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

Midlab Incorporated

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

November 6, 2024 · DrugView details →

Class IIOngoing

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

Midlab Incorporated

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

November 6, 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 IIOngoing

boardwalk ANTIBACTERIAL HANDSOAP REFILL, Chloroxylenol 0.1%, 1 gal. (3.78 L), Manufactured for Essendant Co., One Parkway North, Deerfield, IL 60015

Midlab Incorporated

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

November 6, 2024 · DrugView details →

Class IIOngoing

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

Midlab Incorporated

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

November 6, 2024 · DrugView details →

Class IIOngoing

Genuine Joe Antibacterial Lotion Soap , Chloroxylenol 0.1%, 1 GALLON (3.78L), Manufactured in the U.S.A. for S.P. Richards Co., Atlanta, GA 30339

Midlab Incorporated

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

November 6, 2024 · DrugView details →

Class IIOngoing

Trinity Gold Nutrition, 60 Capsule, 30 day Supply, Distributed by Trinity Gold Nutrition 201 Tom Hall St. Ste. 2107, Fortmill, SC 29716, USA, Ph: 704-629-8203, www.trinitygold.com, Made in India, UPC 802992001009

Trinity Gold Nutrition

Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac and phenylbutazone.

November 6, 2024 · DrugView details →

Class IIOngoing

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

Midlab Incorporated

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

November 6, 2024 · DrugView details →

Class IIOngoing

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, Pithampur, Madhya Pradesh India, NDC 16714-554-01.

Glenmark Pharmaceuticals Inc., USA

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

November 1, 2024 · DrugView details →

Class IIOngoing

Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Rx Only, 100 Capsules, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-562-01.

Glenmark Pharmaceuticals Inc., USA

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

November 1, 2024 · DrugView details →

Class IIOngoing

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, Pithampur, Madhya Pradesh India, NDC 16714-555-01.

Glenmark Pharmaceuticals Inc., USA

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

November 1, 2024 · DrugView details →

Class IIOngoing

Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-850-01.

Glenmark Pharmaceuticals Inc., USA

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

November 1, 2024 · DrugView details →

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