FDA Drug recall D-0477-2022
Cetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
- FDA Drug
- Class II
- terminated
- Published 2022-02-09
On 2022-02-09 the FDA classified a Class II recall of Cetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124 by Ultra Seal, citing cGMP deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0477-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-01-24 |
| Published | 2022-02-09 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ultra Seal |
| Distribution | US |
Product
Cetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
Reason
cGMP deviations
Identifiers
| code_info | Lot #: A-K-9668, Exp. Date 06/2022; A-K-9475, Exp. Date 02/2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0477-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.