Why it was recalled
Labeling: Not elsewhere classified: On 12/12/11, DEA published a final rule in the Federal Register making this product a schedule IV (C-IV)controlled substance. This product is being recalled because this controlled product was not relabeled with the required "C-IV" imprint on the label for products distributed after the 06/11/12 deadline.
Product description
Carisoprodol Tablets, USP, 350 mg Rx Only, 100 tablets per bottle, Rx Only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724, NDC 0143-1176-01.
Lot numbers, UPCs & expiration codes
Lot #: 69160A
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-201-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 30, 2012
- FDA report date
- Mar 27, 2013
- Quantity
- 1763 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- West-ward Pharmaceutical Corp.
Original FDA data
Every field from FDA enforcement report D-201-2013, exactly as published.
Show all FDA fields
- City
- Eatontown
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 64104
- Address
- 465 Industrial Way W
- Code information
- Lot #: 69160A
- Postal code
- 07724-2209
- Report date
- Mar 27, 2013
- Product type
- Drugs
- Recall number
- D-201-2013
- Classification
- Class III
- Recalling firm
- West-ward Pharmaceutical Corp.
- Product quantity
- 1763 bottles
- Termination date
- Dec 18, 2014
- Reason for recall
- Labeling: Not elsewhere classified: On 12/12/11, DEA published a final rule in the Federal Register making this product a schedule IV (C-IV)controlled substance. This product is being recalled because this controlled product was not relabeled with the required "C-IV" imprint on the label for products distributed after the 06/11/12 deadline.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Carisoprodol Tablets, USP, 350 mg Rx Only, 100 tablets per bottle, Rx Only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724, NDC 0143-1176-01.
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 30, 2012
- Initial firm notification
- Letter
- Center classification date
- Mar 15, 2013