FDA Drug recall D-0474-2022
Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1mg) caplets, packaged in a) 90-count bottles, b) 2-count packets, Manufacture…
- FDA Drug
- Class II
- terminated
- Published 2022-02-09
On 2022-02-09 the FDA classified a Class II recall of Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1mg) caplets, packaged in a) 90-count bottles, b) 2-count packets, Manufacture… by Ultra Seal, citing cGMP deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0474-2022 |
| 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
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
Reason
cGMP deviations
Identifiers
| code_info | Lot #: a) 19G074, 19G075, Exp. Date 07/2022; b) 19G075, Exp. Date 07/2022 |
|---|
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-0474-2022%22
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