Cold Relief — Class II drug recall D-0483-2022
Terminated recall by Ultra Seal Corporation, reported 2022-02-09, distributed nationwide. cGMP deviations
| Recall number | D-0483-2022 |
|---|---|
| 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 | 7,858,690 packets |
| Reason classes | cgmp |
| NDC | 42961-0112-03 |
| Lot numbers | 9456, AK9454, AK9456, AK9524, AK9528, AK9564, AK9767, AK9823, AK9824, K9456, K9767 |
| Expiration dates | 2022-01, 2022-03, 2022-04, 2022-08, 2022-09 |
Product
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
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-0483-2022. 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.