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.
Reported: November 25, 2015 Initiated: November 2, 2015 #D-0235-2016
Product Description
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.
Details
- Recalling Firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Units Affected
- 4,609 Packages
- Distribution
- US Nationwide including Puerto Rico
- Location
- Rockford, IL
Frequently Asked Questions
What product 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.. Recalled by Mylan Institutional, Inc. (d.b.a. UDL Laboratories). Units affected: 4,609 Packages.
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-0235-2016.
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