D-0473-2022 Class II Terminated
FDA drug recall D-0473-2022 was initiated by Ultra Seal Corporation on January 24, 2022 and is designated Class II. Reason for recall: cGMP deviations The recall status is terminated (terminated October 16, 2023). Affected quantity: 301,842 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 9, 2022
- Initiation Date
- January 24, 2022
- Termination Date
- October 16, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 301,842 bottles
Product Description
Ephedrine Plus (Ephedrine HCl 25mg, Guaifenesin 200mg) tablets, 24-count bottles, Marketed by: DMD Pharmaceuticals A Division of Dickery Consumer Products, Inc. Noblesville, IN 46060, NDC 65193-320-24
Reason for Recall
cGMP deviations
Distribution Pattern
Nationwide within the United States
Code Information
Lot#: 18M063, Exp. Date 01/2022; 19G076, Exp. Date 09/2022