Phenylephrine IV bags recalled due to sterility validation gaps
Central Admixture Pharmacy Services has recalled 472 phenylephrine IV bags distributed nationwide due to insufficient validation data for sterilization processes.
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: Phenylephrine is administered intravenously, making it a risk-of-harm product. The recall is due to lack of sterility assurance from inadequate validation data. Although no illnesses or injuries have been reported, the potential for serious infection from a contaminated IV medication justifies a High severity rating.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling phenylephrine 50 mg in 0.9% sodium chloride 250 mL IV bags (NDC 72196-7039-1). The recall involves 472 bags distributed nationwide.
The recall is due to a lack of assurance of sterility. The manufacturer failed to provide adequate validation data for decontamination cycles, raising concerns about whether the sterilization processes were sufficient to ensure the product is free from contamination.
Affected lot numbers are 36-251703 (expiration 8/28/2023) and 36-251704 (expiration 8/29/2023). Healthcare providers who have received these products should immediately cease use and contact Central Admixture Pharmacy Services or the FDA with any information about the receipt or use of the recalled product.
The recalled product
- Product
- phenylephrine 50 mg added to 0.9% sodium chloride 250mL, CONCENTRATION = 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.
- Category
- Drug — Intravenous / Injectable
- Affected units
- 472
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 (4)
- Lot: 36-251703
- Exp. 8/28/2023
- 36-251704
- Exp. 8/29/2023
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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