Acetaminophen Injection Recalled for Temperature Storage Abuse Nationwide
Baxter Healthcare recalls 85,680 bags of acetaminophen injection nationwide due to temperature abuse in distribution. Product was shipped in refrigerated trucks despite being labeled for room temperature storage.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving improper storage conditions of an injectable drug; the temperature mismatch between refrigerated transit and room temperature labeling presents a risk of harm to product stability and efficacy, though no illnesses or injuries have been reported.
Plain-English summary
Baxter Healthcare Corporation is recalling 85,680 bags of Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, packaged in VIAFLO single-dose 100 mL containers for intravenous use (NDC 36000-306-60). Affected lot numbers include 20K19G64T1 with expiration 10/31/2022, and lots 21K23G65, 21K25G65, 21K26G65, 21K29G67, 21L10G65, 21L13G66, 21L14G66, 21L15G65 with expiration dates of 10/31/2023 or 11/30/2023.
The recall is due to temperature abuse during distribution. The product was transported in refrigerated trucks bearing labels stating "Refrigerate Upon Arrival," but the product is labeled for storage at controlled room temperature. This mismatch between actual shipping conditions and the labeled storage environment may affect product stability or efficacy.
The product was distributed nationwide in the USA. Healthcare facilities and pharmacies that received affected lots should stop using them and isolate remaining inventory. Patients who received doses from affected lots should contact their healthcare provider. No adverse events have been reported in connection with this recall.
The recalled product
- Product
- ACETAMINOPHEN (ACETAMINOPHEN)
- Brand
- ACETAMINOPHEN
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Drug — Injectable / Intravenous
- Hazard
- temperature-abuse
- improper-storage
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- Lots: 20K19G64T1
- Exp 10/31/2022
- 21K23G65
- 21K25G65
- 21K26G65
- 21K29G67
- Exp 10/31/2023
- 21L10G65
- 21L13G66
- 21L14G66
- 21L15G65
- Exp 11/30/2023
Distribution
Distributed nationwide across the United States.
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