November 2013 FDA Recall Drug by West-ward Pharmaceutical Corp. (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)

This Class II drug recall was voluntarily initiated by West-ward Pharmaceutical Corp. on November 7, 2013 for the product Drug. The FDA reported the reason for recall as presence of foreign substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-367-2014

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
Initiated
11-07-2013
Reported
12-25-2013
Quantity
20,534 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67022
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
West-Ward Pharmaceutical Corp.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-14-2014
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# 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