Vancomycin Injectable Recalled for Lack of Sterility Validation
Central Admixture Pharmacy Services is recalling vancomycin injections nationwide (477 bags, lots 36-262215 and 36-262216) due to lack of validation data for sanitization cycles, which prevents assurance of product 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: This is an FDA Class II recall involving a sterile injectable medication with lack of validated sanitization processes. While no illnesses or injuries have been reported, the potential for microbial contamination in an intravenous drug represents a high-risk hazard to patient safety.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling vancomycin added to 0.9% Sodium Chloride injection nationwide. The recalled product is supplied in 250 mL Excel Bags at a concentration of 1.25 g/250 mL (5 mg/mL). The recall affects 477 bags from lots 36-262215 and 36-262216, which expire October 5, 2023.
The manufacturer initiated the recall because it lacks validation data for the sanitization cycles used to prepare this sterile injectable product. Without documented evidence that sanitization processes adequately eliminate microbial contamination, the sterility of the medication cannot be assured. Sterility is critical for intravenous drugs, as any contamination could cause serious infection.
Healthcare providers should immediately quarantine remaining product from the affected lots and identify alternative sources of vancomycin. Patients who have received doses from these specific lots should contact their healthcare provider. Patients should not discontinue vancomycin without medical guidance, as abrupt cessation could compromise their treatment.
For questions about this recall, contact Central Admixture Pharmacy Services, Inc., located at 2200 South 43rd Avenue, Phoenix, AZ 85043.
The recalled product
- Product
- vancomycin added to 0.9% Sodium Chloride, 1.25 g/250 mL (5 mg/mL), 250mL Excel 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 — Sterile Injectable
- Affected units
- 477
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# 36-262215
- 36-262216
- Exp 10/5/2023.
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.
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