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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 4141–4160 of 17,755 recalls

Class IITerminated

Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, 3 mL bottle, Sterile, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, Made in India, NDC 65862-840-03

Aurobindo Pharma USA Inc.

Failed Impurities/Degradation Specifications

January 14, 2022 · DrugView details →

Class IIOngoing

Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, Distributed by: Mayne Pharma Greenville, NC 27834, NDC 51862-604-50

Mayne Pharma Inc

CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.

January 14, 2022 · DrugView details →

Class IITerminated

Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, 07054, NDC 67877-590-01.

Ascend Laboratories, LLC

Failed Dissolution Specifications.

January 12, 2022 · DrugView details →

Class IITerminated

8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC., Lenoir, NC 28645, NDC 51754-5001-1

Exela Pharma Sciences LLC

Lack of Assurance of Sterility

January 11, 2022 · DrugView details →

Class IITerminated

Lung Cleaner (saline eucalyptus) inhaler, 37 oz cans, Manufactured For: The Lung Cleaner LLC Boulder, CO 80302

Pharmasol Corporation

cGMP deviations

January 11, 2022 · DrugView details →

Class IITerminated

Clobetasol Propionate Foam, 0.05%, packaged in a) 50 g can (NDC 50742-304-50), and b) 100 g can (NDC 50742-304-01), Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408.

Ingenus Pharmaceuticals Llc

CGMP Deviations

January 10, 2022 · DrugView details →

Class IITerminated

Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0808-02

Teva Pharmaceuticals USA

Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution.

January 10, 2022 · DrugView details →

Class IIITerminated

Mucus Relief D, Guaifenesin Pseudoephedrine HCl ER Tablets, 600 mg/60mg, packaged in 36-count blister pack packed into cartons, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, Made in India, NDC 0363-164-3

Dr. Reddy's Laboratories, Inc.

Subpotent drug

January 10, 2022 · DrugView details →

Class IIITerminated

Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx Only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured For: Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0093-5455-42

Teva Pharmaceuticals USA

Mislabeling

January 7, 2022 · DrugView details →

Class IIITerminated

Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured For: Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0093-5455-28

Teva Pharmaceuticals USA

Mislabeling

January 7, 2022 · DrugView details →

Class IITerminated

Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-058-04

VistaPharm, Inc.

Failed Stability Specifications

January 7, 2022 · DrugView details →

Class ITerminated

Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502-0196-71), packaged in Five 3 mL Prefilled Pens per carton (NDC 49502-0196-75), Rx only, Manufactured in Malaysia for: Mylan Specialty L.P., Morgantown, WV, 26505.

Mylan Pharmaceuticals Inc

Labeling: Missing Label: label missing from some Semglee prefilled pens.

January 5, 2022 · DrugView details →

Class IITerminated

Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and epidural use, Rx only, 2 mL Ampule, Warning - May be habit forming, Preservative Free, Manufactured by Akorn, Inc. Lake Forest, IL 60045, NDC 17478-0050-02.

Akorn, Inc.

Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.

January 5, 2022 · DrugView details →

Class IIITerminated

QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets, USP, Allergy & Congestion, 10 Tablets per box, NDC 63868-729-10, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd, Novi, MI 48375, Made in India.

Dr. Reddy's Laboratories, Inc.

Failed Dissolution Specifications

January 4, 2022 · DrugView details →

Class IIITerminated

CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, a) 20 Extended Release Tablets per box, UPC 050428436189, b) 30 Extended Release Tablets per box, UPC 050428290538, Distributed by CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI, 02895, Made in India.

Dr. Reddy's Laboratories, Inc.

Failed Dissolution Specifications

January 4, 2022 · DrugView details →

Class IIITerminated

equate, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine, Pseudoephedrine HCl 120mg/Nasal Decongestant Extended-Release Tablets USP, a) 20 Extended Release Tablets per box, NDC 49035-273-20, b) 30 Extended Release Tablets per box, NDC 49035-273-30, Distributed by: Walmart Inc., Bentonville, AR 72716, Product of India.

Dr. Reddy's Laboratories, Inc.

Failed Dissolution Specifications

January 4, 2022 · DrugView details →

Class IIITerminated

Rugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets USP, 30 Tablets per box, NDC 0536-1242-07, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI, 49152, Made in India.

Dr. Reddy's Laboratories, Inc.

Failed Dissolution Specifications

January 4, 2022 · DrugView details →

Class IIITerminated

Wal-Fex D, Fexofenadine HCl 60mg/Antihistamine & Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended Release Tablets USP, a) 20 Extended Release Tablets per box, NDC 0363-1606-20, b) 30 Extended Release Tablets per box, NDC 0363-1606-30, Distributed by: Walgreen Co, 200 Wilmot Rd., Deerfield, IL 60015, Made in India.

Dr. Reddy's Laboratories, Inc.

Failed Dissolution Specifications

January 4, 2022 · DrugView details →

Class IIITerminated

Dr. Reddys, Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets USP, a) 10 tablets per box, UPC 343598823355, b) 20 tablets per box, UPC 343598823140, c) 30 tablets per box, UPC 343598823317, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, Made in India.

Dr. Reddy's Laboratories, Inc.

Failed Dissolution Specifications

January 4, 2022 · DrugView details →

Class IIITerminated

Rite Aid Pharmacy, Allergy & Congestion, Fexofenadine HCl 60mg & Pseudoephedrine HCl 120mg, Extended Release Tablets USP, 20 Extended-Release Tablets per box, UPC 011822738873, Distributed by Rite Aid, 30 United Lane, Camp Hill, PA 17011, Made in India.

Dr. Reddy's Laboratories, Inc.

Failed Dissolution Specifications

January 4, 2022 · DrugView details →

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