Vancomycin IV Bags Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 4,824 bags of vancomycin IV medication nationwide due to inadequate validation of sterilization processes. The manufacturer cannot confirm proper sterility.
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 injectable medication without validated sterility assurance. While no illnesses or injuries have been reported, this is a risk-of-harm product where the lack of sterilization validation for IV medications presents significant potential for serious infection.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 4,824 bags of vancomycin 1.25 g/250 mL IV solution due to lack of assurance of sterility. The recalled product was distributed nationwide.
The recall stems from inadequate validation of decontamination cycles used in manufacturing. Without validated decontamination procedures, the manufacturer cannot confirm that the product meets sterility requirements necessary for injectable medications that enter the bloodstream directly.
No illnesses or injuries have been reported. However, intravenous medications lacking sterility assurance present a significant potential risk of bacterial contamination and infection.
The recalled product
- Product
- vancomycin 1.25 g/250 mL added to dextrose 5%, 5 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix AZ 85043, NDC: 72196-6073-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Injectable / IV Solution
- Affected units
- 4,824
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: 36-245562
- Exp. 8/2/2023
- 36-254425
- Exp. 9/5/2023
- 36-255129
- Exp. 9/6/2023
- 36-238965
- Exp. 7/10/2023
- 36-256041
- Exp. 9/11/2023
- 36-241129
- 36-241130
- Exp. 7/19/2023
- 36-241438
- Exp. 7/20/2023
- 36-242703
- Exp. 7/26/2023
- 36-243163
- 36-243164
- Exp. 7/27/2023
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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