FDA Drug recall D-1348-2022
Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag, Single Dose Container, For Intravenous Use Only, Rx Only,…
- FDA Drug
- Class II
- terminated
- Published 2022-08-24
On 2022-08-24 the FDA classified a Class II recall of Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag, Single Dose Container, For Intravenous Use Only, Rx Only,… by Baxter Healthcare, citing temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a c….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1348-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-08-04 |
| Published | 2022-08-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag, Single Dose Container, For Intravenous Use Only, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; NDC 36000-306-60
Reason
Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a controlled room temperature environment.
Identifiers
| ndc | 36000-306-60 |
|---|---|
| ndc | 36000-372-40 |
| code_info | Lots: 20K19G64T1, Exp 10/31/2022; 21K23G65, 21K25G65, 21K26G65, 21K29G67, Exp 10/31/2023; 21L10G65, 21L13G66, 21L14G66, 21L15G65, Exp 11/30/2023 |
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-1348-2022%22
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