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

D-1155-2014

January 28, 2014

Class III

Product summary

Firm: Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Event: Event 67393
Status: Terminated
Classification: Class III
Quantity: 3,252 cartons
Official record key: drug-enforcement:D-1155-2014

Official wording

Reason: Failed Impurity/degradation Specification

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

Distribution pattern: US: Nationwide

Derived failure modes

Potency or specification failure
reason.potency_specification_failure · v1.0.0

Failed Impurity/degradation Specification