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.

FDA recall notice · announced November 25, 2015 · Mylan Institutional, Inc. (d.b.a. Udl Laboratories)

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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.

Reason for recall

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

Notes

Distribution: US Nationwide including Puerto Rico
Lot/code information: Lot #: 3060153, Expiry: 08/31/16
Quantity: 4,609 Packages
Status: Terminated
Products in this recall event:
- 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 (D-0235-2016)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.