Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1mg) caplets, packaged in a) 90-count bottles, b) 2-count packets, Manufactured in the USA for Kramer-Novis, San Juan, Puerto Rico 00917, NDC 52083-482-02
Reason
cGMP deviations
Classification
Class II
Status
Terminated
Lot
Lot #: a) 19G074, 19G075, Exp. Date 07/2022; b) 19G075, Exp. Date 07/2022
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.
Ultra Seal Corporation — Class II Recall | MedicineWatch US