D-0509-2016 Class III Terminated
FDA drug recall D-0509-2016 was initiated by Golden State Medical Supply Inc. on Nov 25, 2015 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: Out of specification for impurities. The recall status is terminated (terminated Jun 7, 2016). Affected quantity: 1136 Bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Dec 16, 2015
- Initiation Date
- Nov 25, 2015
- Termination Date
- Jun 7, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1136 Bottles
Product description
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.
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Distribution pattern
U.S. Nationwide
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.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0509-2016
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026