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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 141–160 of 1,000 recalls

Class ITerminated

Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41000 4, NDC 11523-4162-1, Product of Finland 20006105

Bayer Healthcare Pharmaceuticals Inc.

Chemical Contamination: presence of benzene

October 1, 2021 · DrugView details →

Class ITerminated

Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland 20066104 UPC 3 11017 41007 3, NDC 11523-0072-5

Bayer Healthcare Pharmaceuticals Inc.

Chemical Contamination: presence of benzene

October 1, 2021 · DrugView details →

Class ITerminated

LOTRIMIN AF, (Miconazole nitrate 2%), Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-0544-2 UPC 3 11017 41025 7

Bayer Healthcare Pharmaceuticals Inc.

Chemical Contamination: presence of benzene

October 1, 2021 · DrugView details →

Class ITerminated

Coppertone SPORT MINERAL 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02870 1

Beiersdorf Inc

Chemical contamination; presence of benzene

September 30, 2021 · DrugView details →

Class ITerminated

Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02882 4

Beiersdorf Inc

Chemical contamination; presence of benzene

September 30, 2021 · DrugView details →

Class ITerminated

Coppertone SPORT Sunscreen Spray 50, (To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 5%, NET WT 1.6 OZ (45 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 41100 00506 9

Beiersdorf Inc

Chemical contamination; presence of benzene

September 30, 2021 · DrugView details →

Class ITerminated

Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02881 7

Beiersdorf Inc

Chemical contamination; presence of benzene

September 30, 2021 · DrugView details →

Class ITerminated

Coppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02880 0

Beiersdorf Inc

Chemical contamination; presence of benzene

September 30, 2021 · DrugView details →

Class ITerminated

Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial; Diluent for Glucagon, 1 mL syringe. Rx only, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285; Glucagon, NDC: 0002-8031-01

Eli Lilly & Company

SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration.

September 24, 2021 · DrugView details →

Class ITerminated

Ruzurgi (amifampridine) Tablets 10 mg, packaged in 100-count bottles, Rx only, Manufactured by: Jacobus Pharmaceutical Company, Inc, P.O. Box 5290, Princeton, New Jersey 08540, NDC 49938-110-01.

Jacobus Pharmaceutical Company Inc.

Microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic bacteria, yeast, and mold counts.

September 9, 2021 · DrugView details →

Class ITerminated

AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible containers, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7171-17

ICU Medical Inc

Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.

September 3, 2021 · DrugView details →

Class ITerminated

Avicel RC-591 NF (MCC/Carboxymethylcellulose Sodium) NF, bulk powder, 80.0 KG drum, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711

DuPont Nutrition USA, Inc

Microbial Contamination of Non-Sterile Product: Out-of-specification results obtained for total aerobic microbial count (TAMC).

August 27, 2021 · DrugView details →

Class ITerminated

Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit, Each Kit Includes: 1 bottle containing 7.7 g Vancomycin Hydrochloride USP, powder for oral solution and 1 bottle containing 145 mL Grape Flavored Diluent for reconstitution per carton, Rx only, Manufactured for: Azurity pharmaceuticals, Wilmington, MA 01887, NDC 65628-206-05.

Azurity Pharmaceuticals, Inc.

Product Mix-up: Incorrect diluent component included in the kit.

August 24, 2021 · DrugView details →

Class ITerminated

Hydro Pinapple Burn Max Health Thach Dua, packaged in a box containing 20g x 10 goi/sachets, MATXI CORP, UPC 8 936188 880108

Ebay Seller - John Nguyen

Marketed without an approved NDA/ ANDA - presence of undeclared sibutramine

August 11, 2021 · DrugView details →

Class ITerminated

Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903 NDC 70324-326-01

SterRx, LLC

Non-Sterility: firm's third party lab confirmed microbial contamination.

August 10, 2021 · DrugView details →

Class ITerminated

365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE INTERNACIONAL

Je Dois Lavoir LLC

Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market due to safety concerns.

August 2, 2021 · DrugView details →

Class ITerminated

Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 10702-223-21.

KVK-Tech, Inc.

Temperature abuse: the firm received customer complaints of unusual grittiness in the product.

July 2, 2021 · DrugView details →

Class ITerminated

Prairie Wolf Distillery Alcohol Antiseptic 80%, Topical Solution Hand Sanitizer, packaged in a) (16.9oz) 500 mL (UPC 8 60003 31899 7, NDC: 73891-100-14); and b) (20oz) 591 mL (UPC 8 60003 65984 7 NDC: 73891-100-15) bottles, Prairie Wolf Distillery, Guthrie, Oklahoma

Prairie Wolf Spirits

Hand sanitizer packaged in bottles that resemble beverage containers.

June 21, 2021 · DrugView details →

Class ITerminated

Topotecan Injection 4 mg/4mL (1 mg/mL), Single-Dose vial, Teva Pharmaceuticals USA, Inc. North Whales, PA 19454, Carton NDC# 0703-4714-01, Vial NDC# 0703-4714-71

Teva Pharmaceuticals USA

Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. The vial was returned to Teva for further analysis where two other particulates were found and identified as one (1) grey silicone particle and one (1) translucent, colorless cotton fiber.

June 18, 2021 · DrugView details →

Class ITerminated

PremierZEN Platinum 8000 capsule, 1-count blister card (UPC 7 28175 42185 6), packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed by: New Premier Group, Los Angeles, CA 90006

Miracle 8989

Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.

May 18, 2021 · DrugView details →

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