FDA recall D-1095-2014

Teva Pharmaceuticals USA · Class II · drug

Product

Teva Hydroxyzine Pamoate Capsules, USP, 25 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA. NDC 0555-0323-02.

Reason for recall

CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.

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-1095-2014