FDA Drug Class III — Least Serious

Meclizine Hydrochloride Tablets, USP, 25 mg Tablets, Packaged in 10 x 10 Tablet Blister Pack Packages, Rx Only. Manufactured by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977. Mylan. NDC: 51079-090-20.

Hazard

Failed Impurities/Degradation Specifications: Out of specification for impurities.

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Products

Meclizine Hydrochloride Tablets, USP, 25 mg Tablets, Packaged in 10 x 10 Tablet Blister Pack Packages, Rx Only. Manufactured by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977. Mylan. ND
Brand
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
UPC
Lot #: 3060153, Expiry: 08/31/16

Units Affected

4,609 Packages

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