Recalls / Class II
Class IID-1414-2014
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.
- Affected lot / code info
- Lot #: a) 67839A, 67839D, Exp 05/14; 67936A, Exp 02/15; b) 67839B, 67840C, Exp 05/14; 67936B, Exp 02/15; c) 67840A, Exp 05/14; d) 67840B, Exp 05/14; e) 67839C, Exp 05/14
Why it was recalled
Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point.
Recalling firm
- Firm
- West-Ward Pharmaceutical Corp.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 465 Industrial Way W, Eatontown, New Jersey 07724-2209
Distribution
- Quantity
- a) 17,347 bottles, b) 3,015 bottles, c) 1,334 bottles, d) 5,651 bottles, e) 210 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-05-20
- FDA classified
- 2014-07-01
- Posted by FDA
- 2014-07-09
- Terminated
- 2015-05-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1414-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.