AMBI 40PSE/400GFN, 100 tablet bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0408-01
Recall Number: D-513-2013
Firm: TG United, Inc.
Classification: Class II
Status: Terminated
Report Date: 20130612
Initiation Date: 20130130
Termination Date: 20160930
Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product Description
AMBI 40PSE/400GFN, 100 tablet bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0408-01