FDA-Drug2014-03-12Class II
Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA., NDC 0555-0923-02.
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.
Sold states
Nationwide.
Affected count
10405 tablets
Manufactured in
425 Privet Rd, Horsham, PA, United States
Products
Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA., NDC 0555-0923-02.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1092-2014Don't want to check this manually?
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