drugs Class II Updated 2014-03-12

Teva Pharmaceuticals USA recalls Teva Hydroxyzine Pamoate Capsules, USP, 25 mg, 100- count bo

Recalled Product

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

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot # 34016752A, Exp. 09/16. Lot # 34016753A, Exp. 09/16.
View official government recall

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