Drug product
VERSAPHARM Ethambutol Tablets, USP,400 mg, Rx Only a)60 tablets, NDC 61748-014-06, b)90 tablets, NDC 61748-014-09, c)100 tablets, NDC 61748-014-01, d)1000 tablets, NDC 61748-014-10, e) blister pack (10s) 61748-014-11 Manufactured for: VersaPharm Incorporated Marietta, GA 30062-2260, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.
D-189-2013
Product summary
- Event
- Event 64105
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18,825 bottles
- Official record key
drug-enforcement:D-189-2013
Official wording
Reason: Discoloration: Ethambutol Tablets USP 400 mg have tablets cores that may be discolored.
Code information: 68977A; 68977B; 68978B; 68978C; 68979A - exp JUL 2015 68977C; 68978A exp JUL 2013
Distribution pattern: GA
Derived failure modes
-
Unknown
Discoloration: Ethambutol Tablets USP 400 mg have tablets cores that may be discolored.