Ultra Seal product recalled over manufacturing violations
- Recall date
- January 24, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Ultra Seal Corporation recalls Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant (acetaminophen 325 mg, Guaifenesin 200mg, Phenyl…
- Recall number
- D-0465-2022
- FDA classification
- Class II
- Brand / firm
- Ultra Seal Corporation
- Sold / distributed
- Nationwide within the United States
Why it was recalled
cGMP deviations
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5 mg) 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Mason, OH 45040
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