FDA recall D-1155-2014
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) · Class III · drug
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
Reason for recall
Failed Impurity/degradation Specification
Distribution
US: Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2014-01-28
- Report date
- 2014-03-19
- Termination date
- 2015-06-19
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Rockford, IL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1155-2014