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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 3081–3100 of 17,723 recalls

Class IITerminated

Neomycin Sulfate Tablets, USP 500 mg , 100-count bottles, Rx only, Distributed by: TEVA PHARMACEUTICALS USA, INC North Wales, PA 19454, NDC 0093-1177-01

Teva Pharmaceuticals USA Inc

CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ingredient (API) used in the manufacture of Neomycin Sulfate Tablets, USP 500 mg.

August 23, 2022 · DrugView details →

Class IIITerminated

ClomiPRAMINE Hydrochloride Capsules, USP 25mg, 100-count bottles, Rx only, LEADING PHARMA, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-167-01

Leading Pharma, LLC

Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules

August 23, 2022 · DrugView details →

Class ITerminated

PROPOFOL Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL glass fliptop vial (NDC 0409-4699-54) further packaged in a tray of 10 vials (NDC Carton: 0409-4699-24), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

Pfizer Inc.

Presence of particulate matter

August 22, 2022 · DrugView details →

Class IITerminated

Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan Pharmecuticals, Inc., Boca Raton, FL 33432, NDC 76282-708-50.

CIPLA

Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.

August 22, 2022 · DrugView details →

Class IITerminated

Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35.

CIPLA

Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.

August 22, 2022 · DrugView details →

Class IITerminated

Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed By Perrigo, Allegan, MI 49010, NDC 45802-064-36.

Padagis US LLC

CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.

August 17, 2022 · DrugView details →

Class IITerminated

Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Green Tea and Aloe, Family Safe, No Gels, Water Based, 24 Hour Germ Protection with Moisturizers for Sensitive Skin, a) 8 oz bottle, b) 32 oz bottle, and c) 1.7 fl oz or 50 mL bottle, Supplier details: Ultra Chem Labs, Ontario, CA, Active Ingredients - Benzalkonium Chloride 0.13% (antimicrobial), ULS 8357 0.33% (antimicrobial shield), NDC 79208-001-50.

Ultra Chem Labs Corp

Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.

August 15, 2022 · DrugView details →

Class IITerminated

Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Odor Free, Family Safe, No Gels, Water Based, 24 Hour Germ Protection with Moisturizers for Sensitive Skin, a) 8 oz bottle, b) 32 oz bottle and c) 1.7 fl oz or 50 mL bottle, Supplier details: Ultra Chem Labs, Ontario, CA, Active Ingredients - Benzalkonium Chloride 0.13% (antimicrobial), ULS 8357 0.33% (antimicrobial shield), NDC 79208-001-50.

Ultra Chem Labs Corp

Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.

August 15, 2022 · DrugView details →

Class IIOngoing

Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE PRO SERIES, Stain Prevention, 5% Hydrogen Peroxide, Net Wt. 2.1 OZ. (59 g) UPC 0 35000 99658 9. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.

Family Dollar Stores, Llc.

cGMP deviation: Product held outside of appropriate temperature storage conditions.

August 10, 2022 · DrugView details →

Class IIOngoing

Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE with CHARCOAL COOL MINT PASTE, Net Wt. 4.2 OZ. UPC 0 35000 97872 1. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.

Family Dollar Stores, Llc.

cGMP deviation: Product held outside of appropriate temperature storage conditions.

August 10, 2022 · DrugView details →

Class IIOngoing

Colgate Whitening Mouthwash, OPTIC WHITE ICY FRESH MINT. 16 fl. OZ. (1 pt) 473 mL UPC 0 35000 67111 0. Dist. by: Colgate-Palmolive Co. New York, NY 10022 U.S.A.

Family Dollar Stores, Llc.

cGMP deviation: Product held outside of appropriate temperature storage conditions.

August 10, 2022 · DrugView details →

Class IITerminated

PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Unit-Dose Vial, packaged in 30 x 3 mL Sterile Unit-Dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-932-33

Nephron Sterile Compounding Center LLC

CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.

August 10, 2022 · DrugView details →

Class IITerminated

PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-946-34

Nephron Sterile Compounding Center LLC

CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.

August 10, 2022 · DrugView details →

Class IIOngoing

Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE ADVANCED ICY FRESH, Net Wt. 3.2 OZ. (90 g) UPC 0 35000 97159 3. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.

Family Dollar Stores, Llc.

cGMP deviation: Product held outside of appropriate temperature storage conditions.

August 10, 2022 · DrugView details →

Class IITerminated

Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx Only, Nephron Pharmaceutical Corporation 4500 12th Street Extension West Columbia, SV 29172, NDC 0487-6232-01

Nephron Sc Inc

cGMP Deviations: deviations leading to potential cross-contamination.

August 10, 2022 · DrugView details →

Class IIOngoing

Colgate Anticavity Fluoride Toothpaste OPTIC WHITE STAIN FIGHTER CLEAN MINT PASTE. Net Wt. 4.2 OZ. (119 g) UPC 0 35000 45836 0. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.

Family Dollar Stores, Llc.

cGMP deviation: Product held outside of appropriate temperature storage conditions.

August 10, 2022 · DrugView details →

Class IITerminated

PF-0.125% Bupivacaine HCl Injection, USP, 625 mg/500 mL (1.25 mg/mL), 500 mL bag, packaged in 10 x 1 IV Bag per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-970-05

Nephron Sterile Compounding Center LLC

CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.

August 10, 2022 · DrugView details →

Class IITerminated

Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mmol/L, Chloride 86 mmol/L, Citrate 18 mmol/L, 4000 mL IV bag, packaged in 1 x 1 IV bag per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-910-04

Nephron Sterile Compounding Center LLC

CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.

August 10, 2022 · DrugView details →

Class IIOngoing

Colgate Anticavity Fluoride Toothpaste, OPTIC WHITTE RENEWAL, 3% Hydrogen Peroxide, High Impact White, Net Wt. 3.0 OZ. (85 g) UPC 0 35000 97008 4. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.

Family Dollar Stores, Llc.

cGMP deviation: Product held outside of appropriate temperature storage conditions.

August 10, 2022 · DrugView details →

Class IIIOngoing

Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-189-24

Akorn, Inc

Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.

August 8, 2022 · DrugView details →

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