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.
Other recalls by Golden State Medical Supply
- Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC: 51407-445-30
FDA Drug · Class II · 2026-09-09 · Golden State Medical Supply - Carbamazepine Tablets, USP, 200mg, packaged in a)1000-count bottles (NDC 51407-215-10), b) 100-count bottles (NDC 51407-215-01), Rx Only, M…
FDA Drug · Class II · 2026-08-26 · Golden State Medical Supply - GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets, Rx only, Manufactured by Kremers Urban Pharmaceuticals Inc.,…
FDA Drug · Class II · 2026-06-17 · Golden State Medical Supply - Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo…
FDA Drug · Class III · 2026-05-27 · Golden State Medical Supply - Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camaril…
FDA Drug · Class III · 2026-05-27 · Golden State Medical Supply
All Golden State Medical Supply recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0509-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.