Status
Terminated
Drug Enforcement D-578-2013
CGMP Deviation; cotton coil is missing in some packaged bottles
Classification
Class III
Report Date
June 12, 2013
Termination Date
December 24, 2013
Product Information
- Product description
- Disulfiram Tablets USP 250 mg, 100 tablet bottle, Rx only, Manufactured for TEVA Pharmaceuticals, USA, Sellersville, PA --- NDC 0093-5035-01
- Product quantity
- 68,322 bottles
- Reason for recall
- CGMP Deviation; cotton coil is missing in some packaged bottles
- 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-578-2013
- Event ID
- 64680
- Recall initiation date
- March 19, 2013
- Center classification date
- June 6, 2013
- Code info
- NDC 0093-5035-01, Lot numbers 14064211A, exp 3/2014; 14064311A, exp 3/2014; 14064411A, exp 3/2014; 14064511A, exp 3/2014; 14090312A, exp 4/2015; 14092512A, exp 4/2015; 14092712A, exp 4/2015; 14094612A, exp 4/2015; 14099412A, exp 4/2015; 14099612B, exp 4/2015; 14099712A, exp 5/2015; 14110111A, exp 5/2014; 14110211A, exp 5/2014; 14110311A, exp 5/2014; 14110411A, exp 5/2014 and 34090212A, exp 4/2015.
- More code info
- —