Phenylephrine IV Bags Recalled for Sterility Assurance Deficiency
Central Admixture Pharmacy Services recalls 297 bags of phenylephrine IV solution due to lack of validated sanitization procedures. The Class II recall affects nationwide distribution.
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 Class II FDA recall involving lack of validated sterility assurance for intravenous medication. While no illnesses or injuries are reported in the source, the potential for harm from non-sterile IV solutions is significant, as contamination could result in serious infections in patients receiving the medication.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 297 bags of phenylephrine 20mg/250ml (80 mcg/mL) IV solution (NDC: 72196-7025-1, Lot# 36-260037, expiration 10/3/2023). This prescription-only intravenous medication is used to manage blood pressure.
The recall was initiated due to a lack of assurance of sterility. The company did not have adequate validation data for the sanitization cycles used in preparing these IV bags. This failure in process validation could compromise the sterility of the medication.
The affected medication was distributed nationwide in the United States. Healthcare providers and hospitals that received any bags from Lot# 36-260037 should stop using them immediately and quarantine remaining inventory. Patients currently receiving this medication should consult with their healthcare provider about alternative treatment options.
The recalled product
- Product
- PHENYLephrine added to 0.9% sodium chloride, 20mg/250ml (80 mcg/mL), 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 — IV Solution / Injectables
- Affected units
- 297
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# 36-260037
- 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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