Status
Terminated
Drug Enforcement D-842-2013
Labeling -label error on declared strength: unopened, sealed bottle of Terazosin Hydrochloride (HCl) 10mg Capsules contained Terazosin HCl 5 mg Capsules
Classification
Class II
Report Date
August 14, 2013
Termination Date
August 27, 2014
Product Information
- Product description
- Terazosin Hydrochloride Capsules,10 mg, 100-count bottle, Rx only, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-4339-01
- Product quantity
- 6267 bottles
- Reason for recall
- Labeling -label error on declared strength: unopened, sealed bottle of Terazosin Hydrochloride (HCl) 10mg Capsules contained Terazosin HCl 5 mg Capsules
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico
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-842-2013
- Event ID
- 65826
- Recall initiation date
- July 23, 2013
- Center classification date
- August 6, 2013
- Code info
- Lot # N07321, Exp 6/14
- More code info
- —