Class I - Dangerous
Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
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
Class I - Dangerous
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Class I - Dangerous
Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container
Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-306-10
Burel Pharmaceuticals
Class I - Dangerous
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class I - Dangerous
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-304-10
Burel Pharmaceuticals
Class I - Dangerous
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
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.
Class I - Dangerous
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Ondansetron HCI API, Bulk, Manufacturer: Cadila Pharmaceuticals, Ltd., Ankleshwar, Gujarat, India 393002
Cadila Pharmaceuticals Limited
Class I - Dangerous
Microbial Contamination of Non-Sterile Product
Class I - Dangerous
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class I - Dangerous
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class I - Dangerous
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Class I - Dangerous
Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP
Class I - Dangerous
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class I - Dangerous
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Class I - Dangerous
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class I - Dangerous
Failed Stability Specifications; out-of specification value for homogeneity / phase separation.
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
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
Class I - Dangerous
Labeling: Missing Label