Epinephrine IV Bags Recalled Due to Lack of Sanitization Validation
Central Admixture Pharmacy Services is recalling epinephrine IV bags (Lot 36-260047) because sanitization processes lacked adequate validation data. The manufacturer cannot confirm the product meets sterility standards required for injectable medications.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This FDA Class II recall concerns an injectable medication with a sterility assurance defect. While no illnesses or injuries are reported in the source, it involves a risk-of-harm product where potential contamination has not yet resulted in documented patient harm, meeting the rubric criterion for High severity.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 292 bags of epinephrine IV solution (4 mg/250 mL in 0.9% sodium chloride). The affected lot is 36-260047 with an expiration date of October 3, 2023. Distribution was nationwide in the United States.
The FDA issued a Class II recall due to lack of assurance of sterility. The manufacturer did not have adequate validation data to demonstrate that its sanitization cycles were effective. This validation gap creates uncertainty about whether the product meets sterility requirements for injectable medications.
Epinephrine is administered intravenously in emergency and acute care settings. The unvalidated sanitization processes could result in inadequate sterility assurance for this critical medication.
The recalled product
- Product
- EPINEPHrine added to 0.9% sodium chloride, 4mg/250mL (16 mcg/mL), IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-8093-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Affected units
- 292
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 (2)
- Lot# 36-260047
- Exp 10/3/2023.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 32 recalled by Central Admixture Pharmacy Services, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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