FDA recall D-1414-2014

West-Ward Pharmaceutical Corp. · Class II · drug

Product

Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, NDC 0143-1261-01, b) 1000-count bottles, NDC 0143-1261-10, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724; c) 30-count bottles, NDC 61748-013-30, d) 100-count bottles, NDC 61748-013-01, e) 1000-count bottles, NDC 61748-013-10, Mfd. for: VersaPharm Incorporated, Marietta, GA 30062; Mfd. by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.

Reason for recall

Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2014-05-20
Report date: 2014-07-09
Termination date: 2015-05-22
Voluntary/Mandated: Voluntary: Firm initiated
Location: Eatontown, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1414-2014