Reported Nov 25, 2015 · Terminated
Meclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-034-01) 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, 12.5 mg Tablets
- Packaged in a) 100 Ct Bottles (NDC49884-034-01)
- and b) 1000 Ct Bottles (NDC49884-034-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977
- Lot codes and dates
6 of 6 products
Products covered by this recall # Product as published 1 24820001, Expiry: NOV 2015 2 Lot #: 25783601, Expiry: OCT 2016 3 Lot #: 25783801, Expiry: OCT 2016 4 Lot #: 26731201, Expiry: AUG 2017 5 Lot #: 26762002, Expiry: FEB 2018. b) Lot #: 26683201, Expiry: AUG 2017 6 Lot#: 26762001, Expiry: FEB 2018. - Amount recalled
- a) 162,385 Bottles; b) 6949 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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