ED A-HIST TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Edwards Pharmaceuticals Inc., Ripley, MS 38663, NDC 0485-0154-01

Recall Number: D-515-2013

Firm: TG United, Inc.

Classification: Class II

Status: Terminated

Report Date: 20130612

Initiation Date: 20130130

Termination Date: 20160930

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

ED A-HIST TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Edwards Pharmaceuticals Inc., Ripley, MS 38663, NDC 0485-0154-01