FDA Drug recall D-0869-2022
Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distrib…
- FDA Drug
- Class II
- completed
- Published 2022-05-25
On 2022-05-25 the FDA classified a Class II recall of Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distrib… by Plastikon Healthcare, citing CGMP Deviations: Failure to properly investigate failed microbial testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0869-2022 |
| Classification | Class II |
| Status | completed |
| Initiated | 2022-03-24 |
| Published | 2022-05-25 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Plastikon Healthcare |
| Distribution | IN |
Product
Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6820-76.
Reason
CGMP Deviations: Failure to properly investigate failed microbial testing.
Identifiers
| code_info | Lot: 20040A, EXP May 2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0869-2022%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.