FDA-Drug2014-03-12Class II
Teva Hydroxyzine Pamoate Capsules, USP, 100 mg, 100- count bottle,Rx only, Distributed by Teva Pharmaceuticals USA, Sellersville, PA. NDC 0555-0324-02
Teva Pharmaceuticals USA
Hazard
CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 100 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.
Sold states
Nationwide.
Affected count
2494 capsules
Manufactured in
425 Privet Rd, Horsham, PA, United States
Products
Teva Hydroxyzine Pamoate Capsules, USP, 100 mg, 100- count bottle,Rx only, Distributed by Teva Pharmaceuticals USA, Sellersville, PA. NDC 0555-0324-02
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1093-2014Don't want to check this manually?
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