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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 11081–11100 of 17,816 recalls

Class IITerminated

Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Montvale, NJ NDC 67877-217-10

Ascend Laboratories LLC

Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP

November 2, 2016 · DrugView details →

Class IIITerminated

Qnasl (beclomethasone dipropionate) Nasal Aerosol 40 Mcg, 60 Metered Sprays, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044, By: 3M Drug Delivery Systems, Northridge, CA 91324, NDC 59310-206-06 and 59310-206-08 (Physician Samples).

Teva Pharmaceuticals USA

Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.

November 1, 2016 · DrugView details →

Class IITerminated

Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-4093-32

Hospira Inc.

Lack of Assurance of Sterility: Complaints of broken tips on the ampules.

November 1, 2016 · DrugView details →

Class IIITerminated

Qnasl (beclomethasone dipropionate) Nasal Aerosol 80 Mcg, 50 Metered Sprays, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044, By: 3M Drug Delivery Systems, Northridge, CA 91324, NDC 59310-210-13.

Teva Pharmaceuticals USA

Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.

November 1, 2016 · DrugView details →

Class IITerminated

Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830, NDC 42937-702-10.

Nationwide Laboratories, LLC

CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.

October 28, 2016 · DrugView details →

Class ITerminated

Skinny Bee Diet capsules, 500 mg, packaged in a 60-count bottle

Love My Tru Body

Marketed without an approved NDA/ANDA: presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and phenolphthalein.

October 28, 2016 · DrugView details →

Class IIITerminated

KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP, (0.147 mg/g), 15 g bottle, Physician Sample: Not For Sale, Rx only, RANBAXY, Jacksonville, FL 32257, UPC 3 10631 09335 8.

Sun Pharmaceutical Industries, Inc.

Failed Stability Specifications: Low Out of Specification results for alcohol content.

October 28, 2016 · DrugView details →

Class IITerminated

Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830, NDC 42937-701-10.

Nationwide Laboratories, LLC

CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.

October 28, 2016 · DrugView details →

Class IITerminated

Salsalate Tablets, USP, 500 mg, packaged in a) 500 count bottles (NDC 42937-703-18); b) 100 count bottles (NDC 42937-703-10); and c) 1000 count bottles (NDC 42937-703-20); Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830.

Nationwide Laboratories, LLC

CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.

October 28, 2016 · DrugView details →

Class IITerminated

Salsalate Tablets, USP, 750 mg, packaged in a) 100 count bottles (NDC 42937-704-10); b) 500 count bottles (NDC 42937-704-18); and c) 1000 count bottles (NDC 42937-704-20); Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830.

Nationwide Laboratories, LLC

CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.

October 28, 2016 · DrugView details →

Class IIITerminated

Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle (NDC 68001-264-05), b) 500-count bottle (NDC 68001-264-03) , Rx only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India For BluePoint Laboratories

Amerisource Health Services

Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.

October 27, 2016 · DrugView details →

Class IITerminated

Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-306-10

Burel Pharmaceuticals Inc

CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures

October 24, 2016 · DrugView details →

Class IITerminated

AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue 10 mg, Hyoscyamine Sulfate, 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-314-10

Burel Pharmaceuticals Inc

CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures

October 24, 2016 · DrugView details →

Class IITerminated

Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-304-10

Burel Pharmaceuticals Inc

CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures

October 24, 2016 · DrugView details →

Class IITerminated

URAMIT MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 118 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue 10 mg, Hyoscyamine Sulfate, 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-300-10

Burel Pharmaceuticals Inc

CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures

October 24, 2016 · DrugView details →

Class IITerminated

Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration contains: Hyoscyamine Sulfate 0.12 mg, Methenamine 81 mg, Methylene Blue 10.8 mg, Phenyl Salicylate 32.4 mg, Sodium Phosphate Monobasic 40.8 mg, 90 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-301-90

Burel Pharmaceuticals Inc

CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures

October 24, 2016 · DrugView details →

Class IITerminated

Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Methylene Blue, 10 mg; Hyoscyamine Sulfate, 0.12 mg, 100 count, Rx only, Manufactured for: BUREL PHARMACEUTICALS, NDC 35573-315-10

Burel Pharmaceuticals Inc

CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures

October 24, 2016 · DrugView details →

Class IITerminated

UROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains: Methenamine 81.6 mg, Benzoic Acid 9.0 mg, Phenyl Salicylate 36 mg, Methylene Blue 10.8 mg, Hyoscyamine Sulfate 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-307-10

Burel Pharmaceuticals Inc

CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures

October 24, 2016 · DrugView details →

Class IITerminated

UROLET MB URINARY ANTISEPTIC, ANTISPASMODIC Tablets, Each tablet contains: Methenamine 81.6 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue, 10.8 mg; Hyoscyamine Sulfate, 0.12 mg, (a) 30 count (NDC 35573-302-30) and (b) 100 count bottles (NDC 35573-302-10), Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS

Burel Pharmaceuticals Inc

CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures

October 24, 2016 · DrugView details →

Class IITerminated

Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akorn, Inc., Lake Forest, IL 60045, NDC 17478-623-12.

Akorn Inc

Subpotent Drug: concentration of product is less than labeled amount.

October 21, 2016 · DrugView details →

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