Class I - Dangerous
Failed Impurities/Degradation Specifications
💊
Prescription Drugs
💊 Drugs • 12,141 recalls
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0093-8199-28
Teva Pharmaceuticals USA
Class I - Dangerous
Failed Moisture Limits: Water (moisture) content above the approved product specifications.
Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India. NDC#: 62756-200-83
SUN PHARMACEUTICAL INDUSTRIES
Class I - Dangerous
Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
Class I - Dangerous
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Presence of Particulate Matter: Particulate matter identified as fiber.
Class I - Dangerous
Failed Impurities/Degradation Specifications
Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons, Distributed By: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC 69842-0914-39
L. Perrigo Company
Class I - Dangerous
Failed Impurities/Degradation Specifications
Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
Fexofenadine Hydrochloride Tablets, 180 mg, 100-count cartons, Distributed by: Perrigo, Allegan, MI 49010. NDC 45802-847-78
L. Perrigo Company
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Failed Stability Specifications
Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 15-count cartons, Distributed By: Adusa Distribution, LLC, Salisbury, NC 28147. NDC 72476-847-22
L. Perrigo Company
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Presence of Particulate Matter: Particulate matter identified as fiber.
Picnic, Fexofenadine Hydrochloride Tablets, 180 mg, Antihistamine, 90-count cartons, Distributed by: Thirty Madison, Inc., New York, NY 10001. NDC 45 tablets: 80159-112-03
L. Perrigo Company
Class I - Dangerous
Failed Impurities/Degradation Specifications
0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA, NDC 0264-5802-00
B. Braun Medical
Class I - Dangerous
Lack of assurance of sterility: bags have the potential to leak.
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Failed Impurities/Degradation Specifications
Allergy ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg, 180-count cartons, Packaged by: Perrigo, 515 Eastern Ave., Allegan, MI 49010 USA. NDC 63981-847-48
L. Perrigo Company
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Failed Impurities/Degradation Specifications