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
FDA recall notice · announced March 20, 2013 · Teva Pharmaceuticals
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The 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.
Reason for recall
Presence of Foreign Tablets/Capsules: Recall is being conducted due to a foreign capsule found in one bottle.
Notes
Distribution: Nationwide
Lot/code information: Lot # N03029, Exp 03/14
Quantity: 3,913 bottles
Status: Terminated
Products in this recall event:
- 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. (D-193-2013)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.