Meclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-034-01) and b) 1000 Ct Bottles (NDC: 49884-034-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.
Reported: November 25, 2015 Initiated: October 26, 2015 #D-0233-2016
Product Description
Meclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-034-01) and b) 1000 Ct Bottles (NDC: 49884-034-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Details
- Recalling Firm
- Par Pharmaceutical Inc.
- Units Affected
- a) 162,385 Bottles; b) 6949 Bottles
- Distribution
- U.S. Nationwide including Puerto Rico
- Location
- Spring Valley, NY
Frequently Asked Questions
What product was recalled? ▼
Meclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-034-01) and b) 1000 Ct Bottles (NDC: 49884-034-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.. Recalled by Par Pharmaceutical Inc.. Units affected: a) 162,385 Bottles; b) 6949 Bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 25, 2015. Severity: Low. Recall number: D-0233-2016.
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