Kissable Diabetics Foot Cream, NET WT 4 oz (113 g) per tube, Manufactured By: Brands International Corp., Newmarket, ON, L3X 2S2. UPC 6 72008 80925 3
Brands International
Class I - Dangerous
CGMP Deviations: lack of adequate release testing.
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
CGMP Deviations; product intended for quarantine was inadvertently distributed
Class I - Dangerous
Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide
Class I - Dangerous
Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC: 60687-480-21, Unit Dose NDC: 60687-480-11
Amerisource Health Services
Class I - Dangerous
Failed Dissolution Specifications:
Class I - Dangerous
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-11
Amerisource Health Services
Class I - Dangerous
Presence of Foreign Tablets/Capsules
Class I - Dangerous
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class I - Dangerous
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134
Alcon Research
Class I - Dangerous
Non-Sterility
Class I - Dangerous
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Class I - Dangerous
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class I - Dangerous
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Class I - Dangerous
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Class I - Dangerous
Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03
Granules Pharmaceuticals
Class I - Dangerous
Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
Class I - Dangerous
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.