FDAClass IINovember 5, 2014

VERSAPHARM INCORPORATED Ethambutol Hydrochloride recall

VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured for VersaPharm Incorporated Marietta…

Why was VERSAPHARM INCORPORATED Ethambutol Hydrochloride recalled?

Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #68975A, #68976; Exp. 07/15

Product
VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured for VersaPharm Incorporated Marietta…
Recalling firm
West-Ward Pharmaceutical Corp.
Quantity
5,596 HDPE bottles
Distribution
GA
Recall date
November 5, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls