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.
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: 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
- Hazard
- contamination
- sterilization-failure
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.
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