Drug product
Terazosin Hydrochloride Capsules, 2 mg, packaged in a) 100-count bottles (NDC 0093-4337-01); and b) 1000-count bottles (NDC 0093-4337-10), Rx only, Manufactured in India By: Intas Pharmaceuticals Ltd., Ahmedabad, Gujarat, India - 382 210; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960.
D-193-2013
Product summary
- Event
- Event 64233
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,913 bottles
- Official record key
drug-enforcement:D-193-2013
Official wording
Reason: Presence of Foreign Tablets/Capsules: Recall is being conducted due to a foreign capsule found in one bottle.
Code information: Lot # N03029, Exp 03/14
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets