Agency classClass IIOur severity:High FDA (Drugs)·D-1125-2023·Announced 2023-09-06

FDA Recalls Phenylephrine IV Bags Due to Sterility Validation Concerns

Central Admixture Pharmacy Services is recalling 586 bags of phenylephrine IV solution due to lack of validation data for sterilization cycles. These bags may not meet sterility assurance requirements for intravenous use.

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 of an intravenous medication with documented lack of sterilization validation. No illnesses or injuries have been reported in the source text. Per the rubric, Class II recalls without hospitalization reports and with theoretical hazards are rated High (3).

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 586 bags of phenylephrine (10 mg/250 mL) intravenous solution that was distributed nationwide. The product is supplied in IV bags with a concentration of 40 micrograms per milliliter.

The recall is due to a lack of assurance of sterility. Specifically, the manufacturer did not provide adequate validation data for its sanitization cycles. This means the sterilization processes used to manufacture these bags have not been properly validated to ensure the product is free from bacterial and other microbial contamination.

The affected lots are 36-260034 and 36-260033, with an expiration date of October 3, 2023. These lots were distributed to healthcare facilities nationwide.

Healthcare providers who have received these products should immediately quarantine them and not administer them to patients. Patients who have received this medication should consult their healthcare provider if they have any concerns.

The recalled product

Product: PHENYLephrine, added to 0.9% sodium chloride, 10mg/250ml (40mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6058-1.
Manufacturer: Central Admixture Pharmacy Services, Inc.
Category: Drug — Injectable / IV Solution
Hazard: sterility
manufacturing-defect
Affected units: 586

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 (3)

Lot# 36-260034
36-260033
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.

See all 32 products in this recall →

Same manufacturer · Central Admixture Pharmacy Services, Inc.

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FDA (Drugs) · 2023-10-11
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Same hazard · sterility