Reported Nov 25, 2015 · Terminated
Meclizine Hydrochloride Tablets USP, 25 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-035-01) and b) 1000 Ct…
Par Pharmaceutical Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Par Pharmaceutical Inc. · 1 Ram Ridge Rd · Spring Valley, NY · 10977-6714
Is this the product you have?
- Meclizine Hydrochloride Tablets USP, 25 mg Tablets
- Packaged in a) 100 Ct Bottles (NDC49884-035-01)
- and b) 1000 Ct Bottles (NDC49884-035-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977
- Lot codes and dates
19 of 19 products
Products covered by this recall # Product as published 1 25552101, Expiry: AUG 2016 2 Lot#: 25712701, Expiry: SEP 2016 3 Lot #: 25787902, Expiry: NOV 2016 4 Lot #: 26074601, Expiry: JAN 2017 5 Lot #: 26259801, Expiry: APR 2017 6 Lot #: 26220001, Expiry: MAR 2017 7 Lot #: 26579001, Expiry: JUN 2017 8 Lot #: 26731801, Expiry: NOV 2017. b) Lot #: 24502301, Expiry: OCT 2015 9 Lot #: 24505901, Expiry: OCT 2015 10 Lot #: 25787901, Expiry: NOV 2016 11 Lot #: 26074701, Expiry: JAN 2017 12 Lot #: 26259701, Expiry: MAR 2017 13 Lot #: 26575801, Expiry: JUN 2017 14 Lot #: 26579002, Expiry: JUN 2017 15 Lot #: 26682801, Expiry: SEP 2017 16 Lot #: 26682901, Expiry: SEP 2017 17 Lot #: 26731702, Expiry: NOV 2017 18 Lot #: 25960301, Expiry: NOV 2017 19 Lot #: 26764801, Expiry: MAR 2018. - Amount recalled
- a) 387,100 Bottles; b) 63,572 Bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification for impurities.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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