Drug product
VersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tablets, Rx Only, Mfd. for VersaPharm Incorporated Marietta, GA 30065-1509; Mfd. by: West-ward Pharmaceuticals Corp., Eatontown, NJ 07724 NDC 61748-014-06,
D-839-2013
Product summary
- Event
- Event 65582
- Status
- Terminated
- Classification
- Class II
- Quantity
- 118 bottles
- Official record key
drug-enforcement:D-839-2013
Official wording
Reason: Discoloration: Ethambutol HCl Tablets 400 mg is being recalled due to a Out of Specification result for description testing for a surface defect of ink.
Code information: Lot 69968B 03/14
Distribution pattern: GA
Derived failure modes
-
Potency or specification failure
Out of Specification