FDA recall D-174-2013

West-ward Pharmaceutical Corp. · Class II · drug

Product

Isoniazid Tablets 300 mg tablets USP, Rx Only, a) 30 tablets - NDC 61748-013-30, b) 100 tablets - NDC 61748-013-01, Mfd for: VersaPharm Incorporated Marietta, GA 30065-1505, Mfd by: West - Ward Pharmaceutical Corp.., Eatontown, NJ 07724

Reason for recall

Failed Dissolution Specifications; 36 month stability timepoint

Distribution

Key facts

Status: Terminated
Initiation date: 2012-12-04
Report date: 2013-03-06
Termination date: 2014-01-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: Eatontown, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-174-2013