Recalls / Class II
Class IID-242-2013
Product
Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle, Rx only, Mfd. for: Versapharm Incorporated, Marietta, GA; Mfd. by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724; NDC 61748-011-01.
- Affected lot / code info
- Lot #: 68028A, Exp 07/14
Why it was recalled
Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months.
Recalling firm
- Firm
- West-ward Pharmaceutical Corp.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 465 Industrial Way W, N/A, Eatontown, New Jersey 07724-2209
Distribution
- Quantity
- 3, 061 bottles
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2013-03-18
- FDA classified
- 2013-04-03
- Posted by FDA
- 2013-04-10
- Terminated
- 2013-12-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-242-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.