Recalls / Class III
Class IIID-0509-2016
Product
MECLIZINE HYDROCHLORIDE TABLETS, 12.5 mg, Packaged in 1000 ct Bottles, Rx Only. Manufactured by: Par Pharmaceuticals Companies Inc., Spring Valley, NY 10977. Packaged by: GSMS Incorporated, Carmarillo, CA 93012. NDC: 60429-204-10.
- Affected lot / code info
- Lot # GS007205 Expiry: Aug-17; Lot #:GS007344, Expiry: Aug-17; Lot #: GS008089, Expiry: Feb-18; Lot #: GS008842, Expiry: Feb-18; Lot #: GS009055, Expiry: Feb-18; Lot #: GS009131; Expiry: Feb-18.
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Recalling firm
- Firm
- Golden State Medical Supply Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 5187 Camino Ruiz, N/A, Camarillo, California 93012-8601
Distribution
- Quantity
- 1136 Bottles
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2015-11-25
- FDA classified
- 2015-12-04
- Posted by FDA
- 2015-12-16
- Terminated
- 2016-06-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0509-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.