Recalls / Class II
Class IID-193-2013
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.
- Affected lot / code info
- Lot # N03029, Exp 03/14
Why it was recalled
Presence of Foreign Tablets/Capsules: Recall is being conducted due to a foreign capsule found in one bottle.
Recalling firm
- Firm
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 650 Cathill Rd, N/A, Sellersville, Pennsylvania 18960-1512
Distribution
- Quantity
- 3,913 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-01-23
- FDA classified
- 2013-03-08
- Posted by FDA
- 2013-03-20
- Terminated
- 2014-04-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-193-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.