Drug product
Terazosin Hydrochloride Capsules,10 mg, 100-count bottle, Rx only, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-4339-01
D-842-2013
Product summary
- Event
- Event 65826
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6267 bottles
- Official record key
drug-enforcement:D-842-2013
Official wording
Reason: Labeling -label error on declared strength: unopened, sealed bottle of Terazosin Hydrochloride (HCl) 10mg Capsules contained Terazosin HCl 5 mg Capsules
Code information: Lot # N07321, Exp 6/14
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Labeling or packaging
Labeling -label error