D-0483-2022 Class II Terminated
FDA drug recall D-0483-2022 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: 7,858,690 packets.
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
- 7,858,690 packets
Product Description
Cold Relief (acetaminophen 250 mg, guaifenesin 200mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-112-03
Reason for Recall
cGMP deviations
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: K9456, AK9454, 9456, AK9456, Exp. Date 01/2022; AK9524, AK9528 Exp. Date 03/2022; K9767, AK9767, Exp. Date 08/2022; AK9824, AK9823, Exp. Date 09/2022; AK9564, Exp. Date 04/2022