FDA recall D-1092-2014

Teva Pharmaceuticals USA · Class II · drug

Product

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

Reason for recall

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

Distribution

Nationwide.

Key facts

Status: Terminated
Initiation date: 2014-01-24
Report date: 2014-03-12
Termination date: 2014-10-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Horsham, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1092-2014