Teva Pharmaceuticals USA recalls Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA,

Recalled March 12, 2014 · FDA recall D-1092-2014 · Teva Pharmaceuticals USA

Hazard

CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than specified in the product formulation. · FDA Class II

Units

10405 tablets

Sold at

Nationwide.

Description

CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than specified in the product formulation.

Product

Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA., NDC 0555-0923-02.

Manufacturer(s)

Teva Pharmaceuticals USA

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →