Agency classClass IIOur severity:High FDA (Drugs)·D-0968-2023·Announced 2023-08-09

Vancomycin IV Bags Recalled Due to Lack of Sterility Assurance

Central Admixture Pharmacy Services is recalling 2,914 bags of vancomycin IV medication nationwide due to lack of assurance of sterility caused by missing validation data for decontamination cycles.

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 an FDA Class II recall of sterile injectable medication where validation data for sterilization is lacking. Though no illnesses or injuries have been reported, the potential for contamination in direct-injection products constitutes a risk-of-harm scenario.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 2,914 bags of vancomycin 1.5 g/250mL added to 5% dextrose IV bags that were distributed nationwide. The affected lot numbers are: 36-239516 and 36-239517 (expiring 7/12/2023), 36-239989 (expiring 7/13/2023), 36-240798 (expiring 7/17/2023), 36-241133 (expiring 7/19/2023), 36-241981 (expiring 7/24/2023), 36-242717 (expiring 7/26/2023), and 36-245577 (expiring 8/2/2023).

The recall is due to lack of assurance of sterility. Validation data for decontamination cycles is lacking, which means the manufacturer cannot confirm that these IV bags have been properly sterilized and are safe for use.

Healthcare providers and patients who have received any of these products should contact Central Admixture Pharmacy Services or their healthcare provider. Any remaining stock of these products should not be used.

The recalled product

Product: vancomycin 1.5 g/250mL added to 5% dextrose, 6 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6075-1
Manufacturer: Central Admixture Pharmacy Services, Inc.
Category: Drug — IV Admixture
Hazard: sterility-failure
contamination-risk
Affected units: 2,914

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 (15)

Lot: 36-239516
36-239517
Exp. 7/12/2023
36-239989
Exp. 7/13/2023
36-240798
Exp. 7/17/2023
36-241133
Exp. 7/19/2023
36-241981
Exp. 7/24/2023
36-242717
Exp. 7/26/2023
36-245577
Exp. 8/2/2023.

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.

See all 95 products in this recall →

Same manufacturer · Central Admixture Pharmacy Services, Inc.

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