drugs Class II Updated 2014-03-12

Teva Pharmaceuticals USA recalls Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- cou

Recalled Product

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

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot # 34013698A, Exp. 01/16. Lot # 34013699A, Exp. 01/16. Lot # 34013700A, Exp. 01/16. Lot # 34013756A, Exp. 01/16.
View official government recall

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