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.
Reported: December 16, 2015 Initiated: November 25, 2015 #D-0510-2016
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.
Details
- Recalling Firm
- Golden State Medical Supply Inc.
- Units Affected
- a) 737 Bottles; b) 3863 Bottles
- Distribution
- U.S. Nationwide
- Location
- Camarillo, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Golden State Medical Supply Inc.. Units affected: a) 737 Bottles; b) 3863 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-0510-2016.
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