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Class II · ModerateRecall completed

Cold Relief (acetaminophen 250 mg

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: 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
Where it was soldNationwide within the United States
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

cGMP deviations

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Distributed by / forUltra Seal Corporation
NDC42961-112-03
Show the full FDA record
Full product labelCold 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
Recalling firmUltra Seal Corporation
DistributionNationwide within the United States
Quantity7,858,690 packets
Recall initiated2022-01-24
Report date2022-02-09
Recall completed2023-10-16
Recall numberD-0483-2022
ClassificationClass II
FDA statusTerminated
Origin on fileNew Paltz NY United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.