RecallRadar

FDA Drug recall D-242-2013

Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle, Rx only, Mfd. for: Versapharm Incorporated, Marietta, GA

On 2013-04-10 the FDA classified a Class II recall of Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle, Rx only, Mfd. for: Versapharm Incorporated, Marietta, GA by West Ward Pharmaceutical, citing subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-242-2013
ClassificationClass II
Statusterminated
Initiated2013-03-18
Published2013-04-10
Last updated2026-09-13 11:51 UTC
CompanyWest Ward Pharmaceutical
DistributionUS

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.

Reason

Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months.

Identifiers

code_infoLot #: 68028A, Exp 07/14

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-242-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.