Recalls / Class III
Class IIID-1155-2014
Product
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
- Affected lot / code info
- Lots and Expiration Dates: 3037463, Expires 2/2014; 3039466, Expires 3/2014; 3040644, Expires 4/2014; 3043463, Expires 6/2014; 3049568, Expires 3/2015
Why it was recalled
Failed Impurity/degradation Specification
Recalling firm
- Firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1718 Northrock Ct, N/A, Rockford, Illinois 61103-1201
Distribution
- Quantity
- 3,252 cartons
- Distribution pattern
- US: Nationwide
Timeline
- Recall initiated
- 2014-01-28
- FDA classified
- 2014-03-12
- Posted by FDA
- 2014-03-19
- Terminated
- 2015-06-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1155-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.