Class III · Low risk Ongoing
Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-138-05; b) 1000-count bottles, NDC…
Reason Cross Contamination
FDA Drug Recalls
57 recalls · Class III, newest first
Class III · Low risk Terminated
Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and Distributed…
Reason Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
Class III · Low risk Ongoing
Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15 mL…
Reason Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
Class III · Low risk Completed
Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured by: Patheon, Inc. Cincinnati, OH 45237 USA or by…
Reason Presence of foreign tablets/capsules
Class III · Low risk Terminated
BADGER 50, ADVENTURE SPORT MINERAL SUNSCREEN WITH CLEAR ZINC, (uncoated 25% zinc oxide), 2.4 oz., Tin, W.S. Badger Company, Inc…
Reason Labeling: Missing Label: The finished product potentially missing the labeling with the drug facts panel, bar code and directions for use.
Class III · Low risk Completed
Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco Pharma. LLC, NDC 43598-943-90.
Reason Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
Class III · Low risk Terminated
Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical…
Reason Superpotent; sodium benzoate preservative