Status
Terminated
Drug Enforcement D-150-2013
Presence of Foreign Substance: Uncharacteristic blacks spots on tablets.
Classification
Class II
Report Date
February 13, 2013
Termination Date
December 18, 2014
Product Information
- Product description
- Carisoprodol Tablets, USP, 350 mg, packaged in a) 500-count tablets per bottle (NDC 0143-1176-05) and b) 1000-count tablets per bottle (NDC 0143-1176-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.
- Product quantity
- 8,585 bottles
- Reason for recall
- Presence of Foreign Substance: Uncharacteristic blacks spots on tablets.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- West-ward Pharmaceutical Corp.
- Address
-
465 Industrial Way W, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-150-2013
- Event ID
- 64103
- Recall initiation date
- December 7, 2012
- Center classification date
- February 5, 2013
- Code info
- Lot #: 69364A, 69365A, and 69365B, Exp 10/15
- More code info
- —