Why it was recalled
Presence of Foreign Substance; metal particulates were visually observed in the tablets.
Product description
Carisoprodol Tablets, USP, CIV, 350 mg, 500 count bottle, Rx only. Manufactured by Watson Pharma Private Ltd, Verna, Salcette, Goa, 403 722 INDIA. Distributed by: Watson Pharma Ltd, Parsippany, NJ 07054. NDC 0591-5513-05.
Lot numbers, UPCs & expiration codes
Lot # 244152A, exp 01/15.
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-397-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 23, 2013
- FDA report date
- Jan 15, 2014
- Quantity
- 4,439 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Watson Laboratories Inc
Original FDA data
Every field from FDA enforcement report D-397-2014, exactly as published.
Show all FDA fields
- City
- Corona
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 67200
- Address
- 132 Business Center Dr
- Code information
- Lot # 244152A, exp 01/15.
- Postal code
- 92880-1724
- Report date
- Jan 15, 2014
- Product type
- Drugs
- Recall number
- D-397-2014
- Classification
- Class II
- Recalling firm
- Watson Laboratories Inc
- Product quantity
- 4,439 bottles
- Termination date
- Aug 4, 2014
- Reason for recall
- Presence of Foreign Substance; metal particulates were visually observed in the tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Carisoprodol Tablets, USP, CIV, 350 mg, 500 count bottle, Rx only. Manufactured by Watson Pharma Private Ltd, Verna, Salcette, Goa, 403 722 INDIA. Distributed by: Watson Pharma Ltd, Parsippany, NJ 07054. NDC 0591-5513-05.
- Distribution pattern
- Nationwide
- Recall initiation date
- Dec 23, 2013
- Initial firm notification
- Letter
- Center classification date
- Jan 6, 2014