MedicineWatch US
Class II Recall

ULTRAtab Laboratories, Inc.

Product
3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-106-00
Reason
CGMP Deviations
Classification
Class II
Status
Terminated
Lot
Product Code C106L; Bulk lots: 18J080, 18L029, 19A103, 19B063, 19D019, 19F065, Product Code C106LA; Bulk lots: 18K045, 18K046, 18L008, 18L105, 19A068, 19A094, 19A106, 19B009, 19C031, 19C032, 19C033, 19G085, 19H070, 19D018, 19H071, 19H082, 19J027
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.