Recalls / Class II
Class IID-1348-2022
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
- Brand name
- Acetaminophen
- Generic name
- Acetaminophen
- Active ingredient
- Acetaminophen
- Route
- Intravenous
- NDCs
- 36000-306, 36000-372
- FDA application
- ANDA214331
- Affected lot / code info
- Lots: 20K19G64T1, Exp 10/31/2022; 21K23G65, 21K25G65, 21K26G65, 21K29G67, Exp 10/31/2023; 21L10G65, 21L13G66, 21L14G66, 21L15G65, Exp 11/30/2023
Why it was recalled
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.
Recalling firm
- Firm
- Baxter Healthcare Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 85,680 bags
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-08-04
- FDA classified
- 2022-08-16
- Posted by FDA
- 2022-08-24
- Terminated
- 2024-07-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1348-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.