Phenylephrine IV Injection Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services recalls phenylephrine IV bags nationwide because the manufacturer lacks validated sanitization data to ensure sterility. Healthcare providers should identify and quarantine affected inventory.
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: FDA Class II recall with no reported illnesses or injuries. The hazard—lack of sterility assurance in an IV drug due to unvalidated sanitization cycles—poses a risk of serious infection or contamination, meeting the criteria for high-risk products where injury has not yet been reported.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 340 bags of phenylephrine added to 0.9% sodium chloride IV solution (50 mg/250mL, 200mcg/mL) due to lack of sterility assurance. The FDA is conducting this Class II recall because the manufacturer lacks validation data to confirm that their sanitization cycles are effective in preventing contamination.
The affected product (Lot #36-260038, expiration 10/3/2023, NDC 72196-7039-1) was distributed nationwide. IV medications must be sterile to be safely administered to patients.
Healthcare providers and facilities should identify any remaining inventory of the affected lot. Patients who received doses from this product should consult their healthcare provider regarding appropriate follow-up.
The recalled product
- Product
- PHENYLephrine added to 0.9% sodium chloride 50 mg/250mL (200mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043. NDC:72196-7039-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- 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# 36-260038
- 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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