Recalls / Class III
Class IIID-0235-2016
Product
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.
- Affected lot / code info
- Lot #: 3060153, Expiry: 08/31/16
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Recalling firm
- Firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1718 Northrock Ct, N/A, Rockford, Illinois 61103-1201
Distribution
- Quantity
- 4,609 Packages
- Distribution pattern
- US Nationwide including Puerto Rico
Timeline
- Recall initiated
- 2015-11-02
- FDA classified
- 2015-11-13
- Posted by FDA
- 2015-11-25
- Terminated
- 2016-12-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0235-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.