Recalls / Class II
Class IID-0483-2022
Product
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
- Affected lot / code info
- 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
Why it was recalled
cGMP deviations
Recalling firm
- Firm
- Ultra Seal Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 521 Main St, N/A, New Paltz, New York 12561-1609
Distribution
- Quantity
- 7,858,690 packets
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2022-01-24
- FDA classified
- 2022-01-31
- Posted by FDA
- 2022-02-09
- Terminated
- 2023-10-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0483-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.