Why it was recalled
Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing
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.
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-367-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 7, 2013
- FDA report date
- Dec 25, 2013
- Quantity
- 20,534 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- West-Ward Pharmaceutical Corp.
Original FDA data
Every field from FDA enforcement report D-367-2014, exactly as published.
Show all FDA fields
- City
- Eatontown
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 67022
- Address
- 465 Industrial Way W
- Code information
- 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
- Postal code
- 07724-2209
- Report date
- Dec 25, 2013
- Product type
- Drugs
- Recall number
- D-367-2014
- Classification
- Class II
- Recalling firm
- West-Ward Pharmaceutical Corp.
- Product quantity
- 20,534 bottles
- Termination date
- Aug 14, 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
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 7, 2013
- Initial firm notification
- Letter
- Center classification date
- Dec 16, 2013