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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 6061–6080 of 17,773 recalls

Class IITerminated

Bleeding Stop, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808

Herbal Doctor Remedies

CGMP Deviations: These products have been found to be misbranded as unapproved new drugs

March 24, 2020 · DrugView details →

Class IIITerminated

Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2047-01

Mylan Pharmaceuticals Inc.

Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.

March 23, 2020 · DrugView details →

Class ITerminated

Tetracycline HCL Capsules, USP, 500 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 08816. NDC 23155-018-01

Avet Pharmaceuticals, Inc.

Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.

March 23, 2020 · DrugView details →

Class ITerminated

Tetracycline HCL Capsules, USP, 250 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 08816. NDC 23155-017-01

Avet Pharmaceuticals, Inc.

Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.

March 23, 2020 · DrugView details →

Class IITerminated

DRAXIMAGE DTPA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE INJECTION), 20 mg vial, Rx only, Manufactured for: Jubilant Draximage, Inc., Kirkland, Quebec, Canada, NDC 65174-288-05, 67175-288-30

Jubilant Draximage Inc

Failed Stability Specifications

March 19, 2020 · DrugView details →

Class IITerminated

Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 50, packaged in a) 1.5 fl. oz. (44 mL) tottles, UPC: 087052727338; b) 2 Fl. OZ. (59 mL) tubes, UPC: 08705272732; c) 4 FL. OZ. (118 mL) tubes, UPC: 087052727345, Distributed By: Beaumont Products, Inc. Kennesaw, GA 30144

Filltech USA, LLC

Microbial contamination of non-sterile products: positive test for yeast and bacteria.

March 19, 2020 · DrugView details →

Class IITerminated

Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25mg / 0.5ml (22.5mg/ml) 0.5ml per syringe. KEEP FROZEN UNTIL USE AND PROTECT FROM LIGHT SINGLE USE SYRINGE FOR INTRAOCULAR INJECTION Edge Pharma, LLC is an FDA-registered 503B outsourcing facility. This is a compounded (re-packaged) drug. Not for Resale, Hospital/Office use only. Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178

Edge Pharma, LLC

Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.

March 19, 2020 · DrugView details →

Class IITerminated

Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml (25mg/ml), 5 mL per syringe, Rx Only, SYRINGE FOR IM INJECTION, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178, Barcode 0544650505

Edge Pharma, LLC

Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.

March 19, 2020 · DrugView details →

Class IITerminated

Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz (473 mL) bottle, Rx ONLY, pai Pharmaceutical Associates, Inc., Greenville, SC 29605; NDC 0121-0810-16.

PAI Holdings, LLC. dba Pharmaceutical Associates Inc

SubPotent Drug: Low out-of-specification results for assay testing.

March 19, 2020 · DrugView details →

Class IITerminated

Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 30, package in 1.5 fl. oz. (44 mL) tottles, Distributed By: Beaumont Products, Inc. Kennesaw, GA 30144, UPC 020908422698

Filltech USA, LLC

Microbial contamination of non-sterile products: positive test for yeast and bacteria.

March 19, 2020 · DrugView details →

Class IITerminated

Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-198-99

Aurobindo Pharma USA Inc.

CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

March 18, 2020 · DrugView details →

Class IITerminated

Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-060-01

Aurobindo Pharma USA Inc.

CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

March 18, 2020 · DrugView details →

Class IITerminated

Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-058-01

Aurobindo Pharma USA Inc.

CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

March 18, 2020 · DrugView details →

Class IITerminated

Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles, Distributed by: Aurobindo Phama USA, Inc. Dayton, NJ 08810, NDC 13107-105-01

Aurobindo Pharma USA Inc.

CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

March 18, 2020 · DrugView details →

Class IITerminated

Levetiracetam Tablets USP 750 mg 120-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, NDC 65862-247-08

Aurobindo Pharma USA Inc.

CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

March 18, 2020 · DrugView details →

Class IITerminated

Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-046-01

Aurobindo Pharma USA Inc.

CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

March 18, 2020 · DrugView details →

Class IITerminated

Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-031-34

Aurobindo Pharma USA Inc.

CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

March 18, 2020 · DrugView details →

Class IITerminated

Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-053-90

Aurobindo Pharma USA Inc.

CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

March 18, 2020 · DrugView details →

Class IITerminated

Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-059-99

Aurobindo Pharma USA Inc.

CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

March 18, 2020 · DrugView details →

Class IITerminated

Ibuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis, 160 count bottle NDC 0573-1769-89 NDC 0573-1769-95

Glaxosmithkline Consumer Healthcare Holdings

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

March 16, 2020 · DrugView details →

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