D-0484-2022 Class II Terminated
FDA drug recall D-0484-2022 was initiated by Ultra Seal Corporation on Jan 24, 2022 and is designated Class II. Reason for recall: cGMP deviations The recall status is terminated (terminated Oct 16, 2023). Affected quantity: 5,741,384 packets.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 9, 2022
- Initiation Date
- Jan 24, 2022
- Termination Date
- Oct 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0484-2022
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026