Recalls / Class III
Class IIID-0510-2016
Product
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.
- Affected 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.
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Recalling firm
- Firm
- Golden State Medical Supply Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 5187 Camino Ruiz, N/A, Camarillo, California 93012-8601
Distribution
- Quantity
- a) 737 Bottles; b) 3863 Bottles
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2015-11-25
- FDA classified
- 2015-12-04
- Posted by FDA
- 2015-12-16
- Terminated
- 2016-06-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0510-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.