ACETAMINOPHEN Recall D-1348-2022
Description: 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
ACETAMINOPHEN Recall D-1348-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1348-2022 |
| Event ID | 90699 |
| Brand | ACETAMINOPHEN |
| Generic Name | ACETAMINOPHEN |
| Manufacturer | ACETAMINOPHEN |
| Original Package? | 1 |
| Active Substance | ACETAMINOPHEN |
| Drug Route | INTRAVENOUS |
| Distribution | Nationwide in the USA |
| Quantity | 85,680 bags |
| Recall 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. |
| Drug Classification | Class II |
| Drug Code Info | 20220824 |
| Product NDC | 36000-306 |
| Recall Initiation Date | 20220804 |
| Report Date | 20220824 |
| Classification Date | 20220816 |
| Address | 1 Baxter Pkwy Deerfield, IL 60015-4625 United States |
| Recalling Firm | Baxter Healthcare Corporation |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 362O9ITL9D |
| Drug Application Number | ANDA214331 |
| Structured Product Labeling (SPL ID) | 3b1e4460-7502-442c-850c-76adfa404f87 |
| Structured Product Labeling (SPL Set ID) | 0f67c1bd-915b-4681-88dd-22f5154a80b3 |
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