MECLIZINE HYDROCHLORIDE TABLETS — Class III drug recall D-0509-2016
Terminated recall by Golden State Medical Supply Inc., reported 2015-12-16, distributed nationwide. Failed Impurities/Degradation Specifications: Out of specification for impurities.
| Recall number | D-0509-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Golden State Medical Supply Inc., Camarillo, CA, United States |
| Recall initiated | 2015-11-25 |
| Classified | 2015-12-04 |
| Reported by FDA | 2015-12-16 |
| Terminated | 2016-06-07 |
| Distributed | Nationwide (US) |
| Quantity | 1,136 bottles |
| Reason classes | specification failure |
| NDC | 60429-0204-10 |
| Lot numbers | AUG-17, FEB-18, GS007205, GS007344, GS008089, GS008842, GS009055, GS009131 |
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 for recall
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0509-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.