Class II Recall

ULTRAtab Laboratories, Inc.

Product
Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, Phenylephrine HCl 10 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-124-00
Reason
CGMP Deviations
Classification
Class II
Status
Terminated
Lot
Product Codes: C119L Bulk Lots: 18K028
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.