FDA recall D-189-2013

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.

Reason for recall

Discoloration: Ethambutol Tablets USP 400 mg have tablets cores that may be discolored.

Distribution

GA

Key facts

Status

Terminated

Initiation date

2012-11-30

Report date

2013-03-13

Termination date

2014-01-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Eatontown, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-189-2013