Drug & medication recalls

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Meclizine Hydrochloride Tablets, USP, 25 mg Tablets, Packaged in 10 x 10 Tablet Blister Pack Packages, Rx Only. Manufac…

Recall date
November 2, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0235-2016
FDA classification
Class III
Brand / firm
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Sold / distributed
US Nationwide including Puerto Rico

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.

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