Reported Feb 9, 2022 · Terminated
Cold Relief (acetaminophen 250 mg, guaifenesin 200mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid…
Ultra Seal Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ultra Seal Corporation · 521 Main St · New Paltz, NY · 12561-1609
Is this the product you have?
Cold Relief (acetaminophen 250 mgguaifenesin 200mgphenylephrine HCl 5 mg) 2 tablets per packetMfd. for First Aid DirectMasonOH 45040NDC 42961-112-03
- Lot codes and dates
Lot #: K9456AK94549456AK9456Exp. Date 01/2022AK9524AK9528 Exp. Date 03/2022K9767AK9767Exp. Date 08/2022AK9824AK9823Exp. Date 09/2022AK9564Exp. Date 04/2022
- Amount recalled
- 7,858,690 packets
This recall covers 56 products
The agency filed one notice per product. You are reading one of them; the other 55 are below.
43 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
cGMP deviations
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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