EPINEPHrine IV bags recalled for sterility assurance failure
Central Admixture Pharmacy Services recalled 554 bags of EPINEPHrine added to dextrose 5% IV bags nationwide due to insufficient validation of sanitization procedures, creating a lack of sterility assurance.
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: FDA Class II recall of a sterility-critical injectable medication with inadequate sanitization validation. No illnesses or injuries reported, but the hazard presents a significant theoretical risk to patient safety.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 554 bags of EPINEPHrine added to dextrose 5% (4mg/250ml, 16 mcg/mL) IV bags that were distributed nationwide in the USA. The product is supplied as prescription-only intravenous bags.
The recall was initiated because the manufacturer lacked validation data for sanitization cycles used in the preparation of these IV bags. This deficiency resulted in a lack of assurance of sterility for the affected product.
Healthcare providers with patients who have received or are using these IV bags should consult appropriate clinical protocols regarding any potential exposure. The affected lot numbers are 36-262162 and 36-262163, both expiring 10/5/2023.
The recalled product
- Product
- EPINEPHrine added to dextrose 5%, 4mg/250ml (16 mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7018-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Affected units
- 554
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 (3)
- Lot# 36-262162
- 36-262163
- Exp 10/5/2023.
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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