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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 11361–11380 of 17,816 recalls

Class IITerminated

Bactroban Ointment, (Mupirocin Ointment 2%), 22 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1525-44,

GlaxoSmithKline, LLC

Penicillin Cross Contamination

July 18, 2016 · DrugView details →

Class IITerminated

Bactroban Nasal, (Mupirocin Calcium Ointment 2%), 1 gram Single Use Tubes, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0029-1526-11.

GlaxoSmithKline, LLC

Penicillin Cross Contamination

July 18, 2016 · DrugView details →

Class IITerminated

Bactroban Cream, (Mupirocin Calcium Cream 2%), 30 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1527-25,

GlaxoSmithKline, LLC

Penicillin Cross Contamination

July 18, 2016 · DrugView details →

Class ITerminated

Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint (473 mL) bottles, Dist by: Rugby Laboratories, Livonia, MI --- NDC 0536-0590-85

The Harvard Drug Group

Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia

July 15, 2016 · DrugView details →

Class IIITerminated

Children's Qnasl 40 mcg (beclomethasone dipropionate) Nasal Aerosol, 40 mcg per spray, 60 Metered Sprays per canister, 4.9g Net Contents, Rx only; Professional Sample; Manufactured for Teva Respiratory, LLC, Horsham, PA 19044; By: 3M Drug Delivery Systems, Northridge, CA 91324; NDC 59310-206-08.

Teva North America

Failed Content Uniformity Specifications: out of specification test result for spray content uniformity.

July 15, 2016 · DrugView details →

Class IITerminated

Trokendi XR (topiramate) extended-release capsule, 50mg, 30-count blister pack, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850, NDC 17772-102-15

Supernus Pharmaceuticals, Inc.

Superpotent Drug: Failure of assay specifications in the capsule.

July 12, 2016 · DrugView details →

Class IITerminated

Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles, Rx Only Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA; Distributed by: Actavis Pharma, Inc Parsippany, NJ 07054 USA NDC 45963-304-09

Actavis Inc

Failed Dissolution Specifications

July 11, 2016 · DrugView details →

Class IITerminated

Calcium Carbonate 600mg/Vitamin D3 400 International Units tablets, 60-count bottles, Pk By Safecor Health Woburn, MA 01801, NDC 00904323392.

Safecor Health, LLC

CGMP Deviations

July 7, 2016 · DrugView details →

Class IITerminated

Acetylcyst 10% OPHT SOL, 10%, 15 mL bottle, Rx only, Medicap Pharmacy, 2790 W Cherry Lane, Meridian, ID 83642, NDC 99999-9996-94.

Medicap Pharmacy

Lack of Assurance of Sterility: Sterile products were not produced in a controlled, sterile environment.

July 7, 2016 · DrugView details →

Class IITerminated

Acetaminophen 325mg tablets, 120-count bottles, Pk By Safecor Health Woburn, MA 01801, NDC 00904198280.

Safecor Health, LLC

CGMP Deviations

July 7, 2016 · DrugView details →

Class IITerminated

Atorvastatin Calcium 40mg Tablet, 30-count bottles, Rx only, Pk By Safecor Health Woburn, MA 01801, NDC 60505258009

Safecor Health, LLC

CGMP Deviations

July 7, 2016 · DrugView details →

Class IITerminated

Doxycycline100mg Tablets, 14-count bottles, Rx only, Packaged By Safecor Health LLC Woburn, MA 01801, NDC 0143314205

Safecor Health, LLC

CGMP Deviations

July 7, 2016 · DrugView details →

Class IITerminated

Acyclovir 400mg Tablet, 15-count bottles, Rx only, Packaged by Safecor Health, LLC. Woburn, MA 01801, NDC 0093894305

Safecor Health, LLC

CGMP Deviations

July 7, 2016 · DrugView details →

Class IITerminated

Metronidazole 500mg Tablet, 50-count bottles, Rx only, Packaged By Safecor Health LLC Woburn, MA 01801, NDC 5011133402

Safecor Health, LLC

CGMP Deviations

July 7, 2016 · DrugView details →

Class IITerminated

Oxygen Nasal Wash (purified water, xylitol, stabilized oxygen, sodium chloride) solution, .75 oz (22mL) bottle, Distributed by: Let's Talk Health, Chula Vista, CA 91914.

Let's Talk Health, Inc.

Marketed Without An Approved NDA/ANDA: product is an unapproved drug due to nasal decongestant claims as well as not complying with the nasal decongestant final monograph.

July 5, 2016 · DrugView details →

Class IITerminated

Dream Body Extreme Gold 800 mg 30 capsules in a plastic screw on top bottle

Dream Body Weight Loss

Marketed without an approved NDA/ANDA: Undeclared sibutramine.

July 1, 2016 · DrugView details →

Class IITerminated

Dream Body Advanced 400 mg 30 capsules in brown foil packets.

Dream Body Weight Loss

Marketed without an approved NDA/ANDA: Undeclared sibutramine.

July 1, 2016 · DrugView details →

Class IITerminated

Dream Body 450 mg 30 capsules in a plastic screw on top bottle

Dream Body Weight Loss

Marketed without an approved NDA/ANDA: Undeclared sibutramine.

July 1, 2016 · DrugView details →

Class IITerminated

Glipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufactured By: Patheon Pharmaceuticals Inc Cincinnati, OH 45237, NDC 00591-0900-30

Actavis Inc

Failed Dissolution Specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.

June 30, 2016 · DrugView details →

Class IITerminated

TAZORAC (tazarotene) Gel 0.05%, Rx only, For Dermatologic Use Only, Not for Ophthalmic Use, packaged in a) 30 g tubes (NDC: 0023-8335-03, UPC: 300238335036) and b)100 g tubes,(NDC: 0023-8335-10, UPC: 300238335104), Manufactured by: Allergan Inc., Irvine, CA 92512.

Allergan Sales, LLC

Failed Content Uniformity Specifications

June 30, 2016 · DrugView details →

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