D-1155-2014 Class III Terminated
FDA drug recall D-1155-2014 was initiated by Mylan Institutional, Inc. (D.B.A. UDL Laboratories) on Jan 28, 2014 and is designated Class III. Reason for recall: Failed Impurity/degradation Specification The recall status is terminated (terminated Jun 19, 2015). Affected quantity: 3,252 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 19, 2014
- Initiation Date
- Jan 28, 2014
- Termination Date
- Jun 19, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,252 cartons
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
Reason for Recall
Failed Impurity/degradation Specification
Distribution Pattern
US: Nationwide
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1155-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026