Phenylepherine IV bags recalled due to sterility assurance concerns
Central Admixture Pharmacy Services is recalling over 8,300 phenylepherine IV bags nationwide because sterilization procedures were not adequately validated. Sterility cannot be assured for the affected units.
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 a risk-of-harm product (injectable IV medication) where the fundamental safety concern is lack of sterility assurance. Although no illnesses have been reported and this is a Class II recall, IV bags administered intravenously carry inherent risk of serious infection if contaminated. The hazard is theoretical but applies to a high-risk product category per the rubric.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling phenylepherine 20mg/250ml IV bags (NDC 72196-7025-1) due to lack of assurance of sterility. The manufacturer failed to provide adequate validation data for decontamination cycles used during production.
Approximately 8,363 units have been distributed nationwide. The recall affects multiple lot numbers with expiration dates ranging from July through August 2023.
Healthcare facilities that received these IV bags should identify affected inventory using the provided lot numbers and expiration dates. Do not use the recalled units. Healthcare providers and patients should not delay necessary treatment; consult with your healthcare facility for replacement product. No illnesses have been reported to date, but the lack of validated sterilization procedures means these products cannot be assured to be sterile and could pose a risk of infection if administered.
The recalled product
- Product
- PHENYLephrine 20mg/250ml added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7025-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Injectable / IV Bag
- Affected units
- 8,363
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:36-239194
- 36-239195
- Exp.7/10/2023
- 36-240009
- Exp. 7/13/2023
- 36-240799
- Exp.7/17/2023
- 36-241147
- 36-241148
- Exp. 7/19/2023
- 36-241740
- 36-241741
- Exp. 7/21/2023
- 36-242562
- Exp. 7/25/2023
- 36-243531
- Exp. 7/30/2023
- 36-244886
- 36-244961
- Exp. 8/1/2023
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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