Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant — Class II drug recall D-0465-2022
Terminated recall by Ultra Seal Corporation, reported 2022-02-09, distributed nationwide. cGMP deviations
| Recall number | D-0465-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ultra Seal Corporation, New Paltz, NY, United States |
| Recall initiated | 2022-01-24 |
| Classified | 2022-01-31 |
| Reported by FDA | 2022-02-09 |
| Terminated | 2023-10-16 |
| Distributed | Nationwide (US) |
| Quantity | 313,000 packets |
| Reason classes | cgmp |
| Lot numbers | K9824 |
| Expiration dates | 2022-09 |
Product
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
Reason for recall
cGMP deviations
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0465-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.