FDAClass IIApril 10, 2013

Ethambutol Hydrochloride Tablets recall: Subpotent

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

Why was Ethambutol Hydrochloride Tablets recalled?

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

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 #: 68028A, Exp 07/14

Product
Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle, Rx only, Mfd. for: Versapharm Incorporated, Marietta, GA; Mfd. by…
Recalling firm
West-ward Pharmaceutical Corp.
Quantity
3, 061 bottles
Distribution
Nationwide.
Recall date
April 10, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls