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.
What this means for you
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
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.
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