Reported Feb 9, 2022 · Terminated
Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1mg) caplets, packaged in a) 90-count bottles, b) 2-count…
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?
- Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1mg) caplets, packaged in a) 90-count bottles, b) 2-count packets, Manufactured in the USA for Kramer-Novis, San Juan, Puerto Rico 00917, NDC 52083-482-02
- Lot codes and dates
Lot #: a) 19G07419G075Exp. Date 07/2022b) 19G075Exp. Date 07/2022
- Amount recalled
- a) 9,060 bottles, b) 44,700 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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