Cold Relief (acetaminophen 250 mg, guaifenesin 200mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid D
Summary
The FDA issued a Class II for Cold Relief (acetaminophen 250 mg, guaifenesin 200mg, phenylephrine HCl 5 mg) 2 by Ultra Seal Corporation. Reason: cGMP deviations.
Details
Source
Drug Recall
External ID
D-0483-2022
Action Date
2022-02-09
Status
Terminated
Category
drug
Product Description
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
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
Quantity Affected: 7,858,690 packets
Reason for Recall
cGMP deviations
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-24
Company
New Paltz, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 136 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Ultra Seal Corporation has 64 FDA actions in our database, including 64 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ultra Seal Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ultra Seal Corporation have FDA actions?
Ultra Seal Corporation has 64 FDA actions in our database, including 64 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0483-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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