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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 261–280 of 1,000 recalls

Class ITerminated

Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6838-73

Plastikon Healthcare LLC

Microbial Contamination of Non-Sterile Products.

June 7, 2022 · DrugView details →

Class ITerminated

MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6846-73.

Plastikon Healthcare LLC

Microbial Contamination of Non-Sterile Products

June 7, 2022 · DrugView details →

Class ITerminated

Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6839-73

Plastikon Healthcare LLC

Microbial Contamination of Non-Sterile Products.

June 7, 2022 · DrugView details →

Class ITerminated

Artri Ajo King Reforzado con Ortiga y Omega 3 tablets, 500 mg, 100-count bottle, Hecho en Mexico por: PLANTAS MEDICINALES DE MEXICO , Melchor Ocampo No. 55 Local D, Delegacion Xochimilco. C.P. 16800, Mexico, D.F., ASIN B092P4615M, UPC 7 501031 111190

Amazon.com, Inc.

Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.

May 26, 2022 · DrugView details →

Class ITerminated

Ortiga mas Ajo Rey Reforzado con Omega 3, 6 y 9, is packaged in a carton containing 30 tablets (500 mg c/u) in a bottle and 60 capsules (400 mg c/u) in a bottle, Hecho en Mexico por: Omega Nutrition , Jorge Washington No. 108 Col. Las Americas, Hidalgo del Parral, Chihuahua. C.P. 33880, ASIN B084L2XM3Z, UPC 3166557819586

Amazon.com, Inc.

Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.

May 26, 2022 · DrugView details →

Class ITerminated

Artri King Reforzado con Ortiga y Omega 3 tablets, 500 mg, 100-count bottle, Hecho en Mexico por: PLANTAS MEDICINALES DE MEXICO , Melchor Ocampo No. 55 Local D, Delegacion Xochimilco. C.P. 16800, Mexico, D.F., ASIN B084KSV12L, UPC 7 501031 111190

Amazon.com, Inc.

Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.

May 26, 2022 · DrugView details →

Class ICompleted

Artri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, 100-count bottles, Melchor Ocampo No. 55 Local D, Delegacion Xochimilco, C.P. 16800, Mexico, D.F., UPC 7 501031 111190.

Walmart Inc

Marketed Without An Unapproved NDA/ANDA: Product lot found to be tainted with undeclared diclofenac, an FDA approved nonsteroidal anti-inflammatory drug (NSAID) for the treatment of pain and inflammation.

May 24, 2022 · DrugView details →

Class ITerminated

Tegsedi (inotersen) Injection 284 mg/1.5 mL, Rx Only, Sterile solution for Subcutaneous Use, 4 prefilled syringes, each containing 284 mg of inotersen, (equivalent to 300 mg inotersen sodium in 1.5 ml of solution), Distributed by Sobi, Inc. Inc Waltham MA 02451, NDC: 72126-007-01

Akcea Therapeutics, Inc.

Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).

May 23, 2022 · DrugView details →

Class ITerminated

Anagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in India For: TEVA PHARMACEUTICALS USA, Inc., North Wales, PA 19454. NDC 0172-5241-60.

Teva Pharmaceuticals USA Inc

Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.

May 11, 2022 · DrugView details →

Class ITerminated

Tacrolimus (Brand Capsules ) 0.5 mg/mL Suspension, Rx, This is a compounded medication., Valor Compounding Pharmacy, 2461 Shattuck Ave., Berkeley, CA 94704,

Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy

Subpotent drug

April 15, 2022 · DrugView details →

Class ITerminated

Tacrolimus (Brand Capsules ) 0.5 mg/mL Suspension, Rx, This is a compounded medication., Valor Compounding Pharmacy, 2461 Shattuck Ave., Berkeley, CA 94704

Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy

Subpotent drug

April 15, 2022 · DrugView details →

Class ITerminated

Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in a 10 mL Multiple-Dose vial inside a carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Manufactured for: Mylan Specialty L.P., Morgantown, WV 26505, NDC 49502-393-80

Mylan Pharmaceuticals Inc

Labeling: Missing label on the vial

April 12, 2022 · DrugView details →

Class ICompleted

Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Prefilled Pens per box, Marketed by Lilly USA, LLC, Indianapolis, IN 46285, Box NDC 0002-8799-59, Pen NDC 002-7516-59

Cardinal Health Inc.

TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.

April 5, 2022 · DrugView details →

Suave 24-Hour Protection Aerosol Antiperspirant Powder scent, Aluminum Chlorohydrate (19.1%), packaged in a) 4 oz. cans (UPC 0 79400 75150 8), and b) 6 oz. cans (UPC 0 79400 78490 2), Dist. By Unilever, Trumbull, CT 06611

Unilever United States Inc.

Chemical contamination: presence of benzene

March 30, 2022 · DrugView details →

Class ITerminated

Pink Pussycat SENSUAL ENHANCEMENT capsule, 3000mg, 1-count blister card, Manufactured for: Pink Pussycat Products - Chatsworth, CA 91311, UPC 8 91875 00462 6.

Pink Toyz

Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

March 29, 2022 · DrugView details →

Class ITerminated

IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL Single Dose Vial, Rx Only, Teva Pharmaceuticals, USA, Inc., North Wales, PA 19454, NDC 0703-4154-11.

Teva Pharmaceuticals USA Inc

Presence of Particulate Matter: Product was found to contain silica and iron oxide

March 29, 2022 · DrugView details →

Class ITerminated

Mickey Mouse Hand Sanitizer, ethyl alcohol 68%, 2.11 oz./to mL bottle, Best Brands Consumer Products, Inc., c/o Best Brands Sales Company LLC, New York, NY NDC 74530-013-02

Best Brands Consumer Products, Inc.

Chemical Contamination; FDA analysis found product to contain methanol

March 29, 2022 · DrugView details →

Class ITerminated

The Mandalorian Hand Sanitizer, ethyl alcohol 68%, 2.11 oz./60 mL bottles, Best Brands Consumer Products, Inc., c/o Best Brands Sales Company LLC, New York, NY NDC 74530-012-02

Best Brands Consumer Products, Inc.

Chemical Contamination; FDA analysis found product to contain benzene

March 29, 2022 · DrugView details →

Class ICompleted

Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distribute by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6838-73.

Plastikon Healthcare LLC

Microbial Contamination of Non-Sterile Products

March 24, 2022 · DrugView details →

Class ICompleted

MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846-73.

Plastikon Healthcare LLC

Microbial Contamination of Non-Sterile Products

March 24, 2022 · DrugView details →

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