FDA Drug recall D-1485-2022
Acetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only…
- FDA Drug
- Class II
- terminated
- Published 2022-09-14
On 2022-09-14 the FDA classified a Class II recall of Acetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only… by Plastikon Healthcare, citing CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1485-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-06-07 |
| Published | 2022-09-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Plastikon Healthcare |
| Distribution | US |
Product
Acetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6739-71
Reason
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Identifiers
| code_info | Lot # 20062A, 20067A, EXP Jun. 2022; 20092A, 20093A, EXP Sep. 2022; 20101A, 21110A, EXP Oct. 2022; 20108A, EXP Nov. 202…Lot # 20062A, 20067A, EXP Jun. 2022; 20092A, 20093A, EXP Sep. 2022; 20101A, 21110A, EXP Oct. 2022; 20108A, EXP Nov. 2022; 21012A, EXP Jan. 2023; 21044A, 21048B, EXP Apr. 2023; 21053A, EXP May. 2023; 21063B, 21068B, EXP Jun. 2023; 21084B, EXP Jul. 2023; 21090A, EXP Aug. 2023; 21119A, EXP Nov. 2023; 21122B, EXP Dec. 2023; 22001B, 22006A, EXP Jan. 2024; 22017B, EXP Mar. 2024 |
|---|
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-1485-2022%22
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