Status
Terminated
Drug Enforcement D-367-2014
Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing
Classification
Class II
Report Date
December 25, 2013
Termination Date
August 14, 2014
Product Information
- Product description
- Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets. Dist by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724. Mfd by: Shasun Chemicals and Drugs Limited, Unit II, R. S. Na 32, 33, 743 PIMS Rd, Periyakalepet, Pondicherry. 605014 INDIA. NDC 0143-9749-10.
- Product quantity
- 20,534 bottles
- Reason for recall
- Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing
- 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-367-2014
- Event ID
- 67022
- Recall initiation date
- November 7, 2013
- Center classification date
- December 16, 2013
- Code info
- NDC 0143-9749-10 Lot: 1) 10BR001B, Exp Aug-2014 2) 10BR002B, Exp Aug-2014 3) 10BR003B Exp, Aug-2014 4) 10BR004B Exp, Aug-2014 5) 10BR005B Exp, Aug-2014 6) 10BR006B Exp, Aug-2014 7) 11BR001B Exp, Aug-2014 8) 11BR002B Exp, Jul-2015 9) 11BR003B Exp, Jul-2015 10) 11BR004B Exp, Jul-2015 11) 11BR005B Exp, Jul-2015 12) 11BR006B Exp, Jul-2015
- More code info
- —