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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 1141–1160 of 17,683 recalls

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 IIITerminated

Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, Distributed by: MAJOR Pharmaceuticals, Livonia, MI, 48152, USA, NDC 0904-6441-61.

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

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

November 5, 2024 · DrugView details →

ZapMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZapMax, 2108 N St. Sacramento, CA 95816, www.zapmax.com

Boulla LLC

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

November 4, 2024 · DrugView details →

VitalityXtra Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: VitalityXtra, San Francisco, CA www.vitalityxtra.com

Boulla LLC

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

November 4, 2024 · DrugView details →

PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: PeakMax, San Francisco, CA, www.PeakMax.com

Boulla LLC

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

November 4, 2024 · DrugView details →

ZoomMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZoomMax, 2108 N St. Sacramento, CA 95816, www.zoommax.com

Boulla LLC

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

November 4, 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 →

Class IIOngoing

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, Pithampur, Madhya Pradesh India, NDC 16714-553-01.

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 90 mg, Rx Only, 100 Capsules, Manufactured for : Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-851-01.

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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