West-Ward Pharmaceutical Corp. recalls Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, NDC 0143-1261-01, b) 1000-count bottles, NDC
Recalled July 9, 2014 · FDA recall D-1414-2014 · West-Ward Pharmaceutical
Hazard
Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point. · FDA Class II
Units
a) 17,347 bottles, b) 3,015 bottles, c) 1,334 bottles, d) 5,651 bottles, e) 210 bottles
Sold at
Nationwide
Description
Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point.
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.
Manufacturer(s)
West-Ward Pharmaceutical Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →