Acetaminophen Oral Solution — Class II drug recall D-0869-2022
Completed recall by Plastikon Healthcare LLC, reported 2022-05-25, distributed in IN. CGMP Deviations: Failure to properly investigate failed microbial testing.
| Recall number | D-0869-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Plastikon Healthcare LLC, Lawrence, KS, United States |
| Recall initiated | 2022-03-24 |
| Classified | 2022-05-13 |
| Reported by FDA | 2022-05-25 |
| Distributed | IN |
| Quantity | 121,800 units |
| Reason classes | microbial contamination, cgmp |
| NDC | 00904-6820-76 |
| Lot numbers | 20040A |
| Expiration dates | 2022-05-20 |
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 for recall
CGMP Deviations: Failure to properly investigate failed microbial testing.
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-0869-2022. 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.