Isoniazid Tablets

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

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.

Recalling firm: West-Ward Pharmaceutical Corp.
NDC code: 0143-1261-01
Origin: NJ, United States
Initiated by: Voluntary: Firm initiated
FDA recall number: D-1414-2014

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Isoniazid recalls

See all

Class II · Moderate risk Terminated Jul 2, 2013

Isoniazid

Reason Labeling: Label Mixup: ISONIAZID, Tablet, 300 mg may have potentially been mislabeled as one of the following drugs: hydrOXYzine PAMOATE, Capsule, 100 mg, NDC 00555032402, Pedigree: W003690, EXP: 6/26/2014; CETIRIZINE HCL, Tablet, 5 mg, NDC 00378363501, Pedigree: AD32757_13, EXP: 5/13/2014; RANOLAZINE ER, Tablet, 500 mg, NDC 61958100301, Pedigree: AD32757_47, EXP: 5/13/2014; DULoxetine HCl DR,

Aidapak Services, LLC D-949-2014

Class II · Moderate risk Terminated Dec 4, 2012