Epinephrine IV solution bags recalled due to inadequate sterilization validation
Central Admixture Pharmacy Services is recalling 6,784 bags of Epinephrine IV solution nationwide because validation data for decontamination and sterilization processes is lacking, 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 an injectable medication where sterilization validation data is lacking, creating a potential contamination risk. No illnesses, injuries, or confirmed contamination have been reported. Per the severity rubric, when a theoretical hazard exists without reported harm, the classification is High (score 3).
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 6,784 bags of Epinephrine added to dextrose 5% (4mg/250ml) IV solution. The recall affects products distributed nationwide and was initiated because validation data for decontamination cycles is lacking, preventing assurance that the product meets sterility requirements. Multiple lot numbers are affected with expiration dates ranging from July through September 2023.
The FDA classified this recall as Class II. No illnesses, injuries, or confirmed contamination have been reported to date. However, the lack of validated sterilization processes creates a potential risk that unsterile product could reach patients. Healthcare providers and patients who have received affected units should consult with their healthcare provider and the manufacturer for guidance.
Affected lot numbers include: 36-239245, 36-241047, 36-241440, 36-241441, 36-241442, 36-242432, 36-243662, 36-246152, 36-246153, 36-246158, 36-246730, 36-246731, 36-246732, 36-247332, 36-247334, 36-247337, 36-249469, 36-249589, 36-250300, 36-251335, and 36-254370.
The manufacturer is located at 2200 South 43rd Avenue, Phoenix, Arizona.
The recalled product
- Product
- EPINEPHrine added to dextrose 5%, 4mg/250ml, 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.
- Category
- Drug — Injectable IV Solution
- Affected units
- 6,784
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 (20)
- Lot: 36-239245
- Exp. 7/10/2023
- 36-241047
- Exp. 7/18/2023
- 36-241440
- 36-241441
- 36-241442
- Exp. 7/20/2023
- 36-242432
- Exp. 7/25/2023
- 36-243662
- Exp. 7/30/2023
- 36-246152
- 36-246153
- 36-246158
- Exp. 8/3/2023
- 36-246730
- 36-246731
- 36-246732
- Exp. 8/6/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 95 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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