Why it was recalled
Failed Impurity/degradation Specification
Product description
Carisoprodol Tablets, USP, 350 mg, unit dose blister packages of 100 tablets (10 cards of 10 tablets each), Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL NDC 51079-819-20
Lot numbers, UPCs & expiration codes
Lots and Expiration Dates: 3037463, Expires 2/2014; 3039466, Expires 3/2014; 3040644, Expires 4/2014; 3043463, Expires 6/2014; 3049568, Expires 3/2015
Where it was sold
US: 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-1155-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 28, 2014
- FDA report date
- Mar 19, 2014
- Quantity
- 3,252 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Original FDA data
Every field from FDA enforcement report D-1155-2014, exactly as published.
Show all FDA fields
- City
- Rockford
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 67393
- Address
- 1718 Northrock Ct
- Code information
- Lots and Expiration Dates: 3037463, Expires 2/2014; 3039466, Expires 3/2014; 3040644, Expires 4/2014; 3043463, Expires 6/2014; 3049568, Expires 3/2015
- Postal code
- 61103-1201
- Report date
- Mar 19, 2014
- Product type
- Drugs
- Recall number
- D-1155-2014
- Classification
- Class III
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Product quantity
- 3,252 cartons
- Termination date
- Jun 19, 2015
- Reason for recall
- Failed Impurity/degradation Specification
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Carisoprodol Tablets, USP, 350 mg, unit dose blister packages of 100 tablets (10 cards of 10 tablets each), Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL NDC 51079-819-20
- Distribution pattern
- US: Nationwide
- Recall initiation date
- Jan 28, 2014
- Initial firm notification
- Letter
- Center classification date
- Mar 12, 2014