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Prescription Drugs

💊 Drugs • 12,141 recalls

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

Class I - Dangerous

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

Oct 28, 2016 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

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

Oct 24, 2016 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

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

Oct 24, 2016 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

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

Oct 24, 2016 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

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

Oct 28, 2016 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

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

Nov 2, 2016 Prescription Drugs View Details →

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

Class I - Dangerous

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

Oct 24, 2016 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

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

Oct 28, 2016 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

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

Oct 24, 2016 Prescription Drugs Nationwide View Details →

AHP NIFEdipine Capsules, 10mg USP, 100 count carton (NDC: 68084-022-01); Individual Blister (NDC: 68084-022-11), Rx Only, Manufactured by: Actavis Elizabeth, LLC, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217

Amerisource Health Services

Class I - Dangerous

Presence of Foreign Tablets/Capsules

Oct 13, 2016 Prescription Drugs View Details →

Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 0143-1455-01

West-Ward Pharmaceuticals

Class I - Dangerous

Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point

Oct 3, 2016 Prescription Drugs Nationwide View Details →

Ceftriaxone for Injection, USP, 1 gram, 10 Single use Vials, Rx only, For IM or I.V. Use, Manufactured by: Sandoz GMbH for Hospira Worldwide, Inc., Lake Forest, Il 60045, USA, Made in Austria, NDC 0409-7332-01

Sandoz

Class I - Dangerous

Labeling: Missing Label

Oct 19, 2016 Prescription Drugs View Details →

Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-count bottle (NDC 0378-5220-05), Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA

Mylan Pharmaceuticals

Class I - Dangerous

Failed Impurities/Degradation Specifications: OOS results for known compound.

Nov 3, 2016 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

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

Oct 28, 2016 Prescription Drugs Nationwide View Details →

Lactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01), packaged in 15 mL x 50 unit dose cups per case (NDC 66689-039-50), Rx only, Manufactured by VistaPharm, Inc., Largo, FL 33771.

VistaPharm

Class I - Dangerous

Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.

Nov 9, 2016 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

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

Nov 1, 2016 Prescription Drugs Nationwide View Details →

Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, P.O. Box 183400, Amman 11118 - Jordan, NDC 0143-9887-01

West-Ward Pharmaceuticals

Class I - Dangerous

Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.

Nov 4, 2016 Prescription Drugs Nationwide View Details →

NIFEdipine Capsules USP, 10 mg, Rx only, 100 count bottle, Manufactured and distributed by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-2407-10

Actavis Elizabeth

Class I - Dangerous

Presence of Foreign Tablets/Capsules

Oct 6, 2016 Prescription Drugs View Details →

BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA inc. Pennington, NJ 08534, NDC 68382-354-05

Zydus Pharmaceuticals USA

Class I - Dangerous

Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.

Aug 3, 2016 Prescription Drugs Nationwide View Details →

LEVOXYL(R) (levothyroxine sodium tablets, USP), 200 mcg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620, NDC 60793-860-01

Pfizer

Class I - Dangerous

Superpotent

Nov 7, 2016 Prescription Drugs Nationwide View Details →

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