Class III
Terminated
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.
This recall has been terminated (originally issued December 16, 2015).
- Company
- Golden State Medical Supply Inc.
- Recall Initiated
- November 25, 2015
- Posted
- December 16, 2015
- Recall Number
- D-0510-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 737 Bottles; b) 3863 Bottles
- Firm Location
- Camarillo, CA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Distribution
U.S. Nationwide
Lot / Code Info
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.
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