D-0510-2016 Class III Terminated
FDA drug recall D-0510-2016 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: a) 737 Bottles; b) 3863 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
- a) 737 Bottles; b) 3863 Bottles
Product description
MECLIZINE HYDROCHLORIDE TABLETS, 25 mg, Packaged in a) 100 ct Bottles (NDC: 60429-205-01) and b) 1000 ct Bottles (NDC: 60429-205-10), Rx Only. Manufactured by: Par Pharmaceuticals Companies Inc., Spring Valley, NY 10977. Packaged by: GSMS Incorporated, Carmarillo, CA 93012.
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Distribution pattern
U.S. Nationwide
Code information
a) Lot #: GS005224, Expiry: Jul-16, Lot:#: GS007553, Expiry: Nov-17; Lot #: GS007858, Expiry: Nov-17. b) Lot #: GS002674, Expiry: Jan-16; Lot #: GS003402, Expiry:May-16; Lot #: GS003582, Expiry: Jun-16; Lot #: GS004899, Expiry: Jun-16; Lot #: GS005908, Expiry: Jun-17; Lot #: GS006088, Expiry: Jun-17; Lot #: GS006254, Expiry: Sep-17; Lot #: GS007345, Expiry: Nov-17; Lot #: GS007664, Expiry: Nov-17; Lot #: GS007803, Expiry: Nov-17; Lot #: GS008091, Expiry: Nov-17.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0510-2016
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026