FDA Recalls EPINEPHrine IV Bags for Unvalidated Sterilization Processes
Central Admixture Pharmacy Services is recalling 340 bags of epinephrine IV solution due to inadequate validation of sterilization procedures, creating a potential contamination risk.
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 is an FDA Class II recall of a sterile injectable drug involving unvalidated sterilization processes that poses a genuine contamination risk. No illnesses or injuries have been reported, so per the rubric this qualifies as a risk-of-harm product without reported injury, resulting in a High (3) severity score.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling EPINEPHrine 2 mg in dextrose 5% solution, supplied in 250 mL IV bags at a concentration of 8 mcg/mL. The recall affects 340 bags with lot number 36-260049 and an expiration date of October 3, 2023. The product was distributed nationwide in the USA.
The recall was initiated because the sanitization cycles used in manufacturing the IV bags were not adequately validated to provide assurance of sterility. This means the sterilization processes cannot be confirmed to have effectively removed microbial contamination.
Hospitals and healthcare facilities that received these IV bags should immediately discontinue use and return the product to the manufacturer. If doses have already been administered, patients should consult their healthcare provider. Healthcare providers should monitor patients for signs of infection.
The recalled product
- Product
- EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6030-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Intravenous Injection
- Affected units
- 340
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# 36-260049
- 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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