Status
Terminated
Drug Enforcement D-193-2013
Presence of Foreign Tablets/Capsules: Recall is being conducted due to a foreign capsule found in one bottle.
Classification
Class II
Report Date
March 20, 2013
Termination Date
April 3, 2014
Product Information
- Product description
- 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.
- Product quantity
- 3,913 bottles
- Reason for recall
- Presence of Foreign Tablets/Capsules: Recall is being conducted due to a foreign capsule found in one bottle.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
- Address
-
650 Cathill Rd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-193-2013
- Event ID
- 64233
- Recall initiation date
- January 23, 2013
- Center classification date
- March 8, 2013
- Code info
- Lot # N03029, Exp 03/14
- More code info
- —