D-0235-2016 Class III Terminated
FDA drug recall D-0235-2016 was initiated by Mylan Institutional, Inc. (D.B.A. UDL Laboratories) on Nov 2, 2015 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: Out of specification for impurities. The recall status is terminated (terminated Dec 21, 2016). Affected quantity: 4,609 Packages.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 25, 2015
- Initiation Date
- Nov 2, 2015
- Termination Date
- Dec 21, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,609 Packages
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.
Distribution Pattern
US Nationwide including Puerto Rico
Code Information
Lot #: 3060153, Expiry: 08/31/16
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0235-2016
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026