FDA Recalls Vancomycin IV Bags Over Sterility Assurance Deficiency
Central Admixture Pharmacy Services is recalling 1,927 bags of vancomycin IV bags (750 mg/250 mL) distributed nationwide due to lack of sterility assurance and insufficient decontamination validation.
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 an injectable drug with potential contamination due to missing sterilization validation. Although illnesses or injuries are not reported, unsterile intravenous medications present a significant risk of harm, meeting the rubric criteria for High severity.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 1,927 bags of vancomycin 750 mg/250 mL in 0.9% Sodium Chloride injection (3 mg/mL), sold under NDC 72196-6071-1. The product is distributed nationwide as a prescription-only intravenous medication.
The recall is due to a lack of assurance of sterility and inadequate validation data for the decontamination cycles used in preparation. These deficiencies create a risk that the products may not be sterile or free from contamination.
Affected lot numbers and expiration dates include: 36-239990 (7/13/2023), 36-240839 (7/18/2023), 36-242706 (7/26/2023), 36-243952 (7/31/2023), 36-253889 (8/31/2023), and 36-255691 (9/7/2023). Healthcare facilities and patients should stop use of affected lots and consult their pharmacy or physician regarding disposal and alternative treatment options.
The recalled product
- Product
- vancomycin 750 mg/250 mL added to 0.9% Sodium Chloride, (3 mg/mL), IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6071-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Injectable
- Affected units
- 1,927
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 (12)
- Lot: 36-239990
- Exp. 7/13/2023
- 36-240839
- Exp. 7/18/2023
- 36-242706
- Exp. 7/26/2023
- 36-243952
- Exp. 7/31/2023
- 36-253889
- Exp. 8/31/2023
- 36-255691
- Exp. 9/7/2023.
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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