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.
Reported: December 16, 2015 Initiated: November 25, 2015 #D-0509-2016
Product Description
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.
Details
- Recalling Firm
- Golden State Medical Supply Inc.
- Units Affected
- 1136 Bottles
- Distribution
- U.S. Nationwide
- Location
- Camarillo, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Golden State Medical Supply Inc.. Units affected: 1136 Bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 16, 2015. Severity: Low. Recall number: D-0509-2016.
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