Agency classClass IIOur severity:High FDA (Drugs)·D-0955-2023·Announced 2023-08-09

Vancomycin IV Bags Recalled Due to Sterility Assurance Concerns

Central Admixture Pharmacy Services is recalling 15,304 bags of vancomycin IV solution due to lack of validation data confirming proper sterilization of the product.

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 FDA Class II recall involves a sterile injectable drug with lack of sterility assurance due to missing validation data for decontamination cycles. The hazard is theoretical rather than based on actual contamination events, and no illnesses or injuries have been reported, placing it at the High (3) level per the rubric.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 15,304 bags of vancomycin 1.25 g/250 mL added to 0.9% Sodium Chloride IV injection (NDC: 72196-6074-1). The product was distributed nationwide, and multiple lot numbers are affected with expiration dates ranging from July through September 2023.

The recall is due to lack of assurance of sterility. The manufacturer lacks validation data demonstrating that its decontamination cycles are effective. Inadequate sterilization of intravenous medications can result in contaminated products being administered to patients.

No illnesses or adverse events have been reported in relation to this recall. Healthcare facilities that received the affected product should discontinue use immediately and follow proper procedures for product disposal or return to the manufacturer.

For more information, healthcare providers and patients may contact Central Admixture Pharmacy Services, Inc. at 2200 South 43rd Avenue, Phoenix, AZ 85043.

The recalled product

Product: vancomycin 1.25 g/250 mL added to 0.9% Sodium Chloride, 5 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6074-1
Manufacturer: Central Admixture Pharmacy Services, Inc.
Category: Drug — Intravenous Injectable
Hazard: contamination
sterility
Affected units: 15,304

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 (20)

Lot: 36-254431
Exp. 9/5/2023
36-255125
36-255126
36-255127
Exp. 9/6/2023
36-248083 Exp. 8/10/2023
36-238973
36-238980
Exp. 7/10/2023
36-239520
Exp. 7/12/2023
36-240087
Exp. 7/13/2023
36-248979
36-248980
36-248981
Exp. 8/16/2023
36-240760
36-240761

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.

See all →

Moderate
Pediatric TPN Bags Recalled for Incorrect Formulation
FDA (Drugs) · 2026-08-12
Severe
Pediatric Total Parenteral Nutrition Bag Recalled for Incorrect Formulation
FDA (Drugs) · 2026-07-01
Severe
Injectable Phenylephrine Solution Recalled Due to Particulate Matter Contamination
FDA (Drugs) · 2025-03-19
High
Ephedrine Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-10-11
High
Fentanyl injectable syringes recalled nationwide for sterility assurance failure
FDA (Drugs) · 2023-10-11

Same hazard · contamination