Drug 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.

D-0509-2016

November 25, 2015

Class III

Product summary

Firm: Golden State Medical Supply Inc.
Event: Event 72733
Status: Terminated
Classification: Class III
Quantity: 1136 Bottles
Official record key: drug-enforcement:D-0509-2016

Official wording

Reason: Failed Impurities/Degradation Specifications: Out of specification for impurities.

Code information: 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.

Distribution pattern: U.S. Nationwide

Derived failure modes

Potency or specification failure
reason.potency_specification_failure · v1.0.0

Out of specification