FDA Drug recall D-0509-2016
MECLIZINE HYDROCHLORIDE TABLETS, 12.5 mg, Packaged in 1000 ct Bottles, Rx Only
- FDA Drug
- Class III
- terminated
- Published 2015-12-16
On 2015-12-16 the FDA classified a Class III recall of MECLIZINE HYDROCHLORIDE TABLETS, 12.5 mg, Packaged in 1000 ct Bottles, Rx Only by Golden State Medical Supply, citing failed Impurities/Degradation Specifications: Out of specification for impurities.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0509-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-11-25 |
| Published | 2015-12-16 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Golden State Medical Supply |
| Distribution | US |
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.
Reason
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Identifiers
| code_info | Lot # GS007205 Expiry: Aug-17; Lot #:GS007344, Expiry: Aug-17; Lot #: GS008089, Expiry: Feb-18; Lot #: GS008842, Expiry…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0509-2016%22
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