D-0484-2022 Class II Terminated
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
- 5,741,384 packets
Product Description
Headache & Congestion Sinus Relief (acetaminophen 250 mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-0206-02
Reason for Recall
cGMP deviations
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 9445, AK9445, K9445, Exp. Date 01/2022; K9486, Exp. Date 02/2022; AK9708, Exp. Date 07/2022; AK9515, Exp. Date 03/2022; K9810, Exp. Date 09/2022; AK9658, Exp. Date 06/2022