Vancomycin IV Bags Recalled Nationwide for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 3,980 IV vancomycin bags nationwide. The decontamination process was not properly validated, raising sterility concerns. No illnesses reported.
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: FDA Class II recall of sterile injectable medication due to lack of validated decontamination processes and sterility assurance. No illnesses or injuries reported, meeting the high-severity threshold for risk-of-harm products.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 3,980 bags of vancomycin 1g/250mL IV solution nationwide. The recall was initiated due to lack of assurance of sterility. Validation data for decontamination cycles used in the manufacturing process is lacking, meaning the bags may not meet sterility requirements.
Vancomycin is an injectable antibiotic administered intravenously to treat serious bacterial infections. Sterility is critical for IV medications—contamination could expose patients to dangerous microbiological infections. Affected lot numbers are: 36-245576, 36-254436, 36-254442, 36-255131, 36-256045, 36-239523, 36-248987, 36-240797, 36-241979, 36-242705, 36-251733, and 36-251738, with various expiration dates through September 2023.
Healthcare facilities that received affected bags should immediately quarantine them and verify lot numbers against the FDA's recall notice. Patients who received injections from recalled bags are advised to consult their healthcare provider about potential infection risks. No illnesses have been reported at this time.
The recalled product
- Product
- vancomycin 1 g/250 mL added to 0.9% sodium chloride, 4 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6064-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Hazard
- lack-of-sterility
- contamination-risk
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: 36-245576
- Exp. 8/2/2023
- 36-254436
- 36-254442
- Exp. 9/5/2023
- 36-255131
- Exp. 9/6/2023
- 36-256045
- Exp. 9/11/2023
- 36-239523
- Exp. 7/12/2023
- 36-248987
- Exp. 8/16/2023
- 36-240797
- Exp. 7/17/2023
- 36-241979
- Exp. 7/24/2023
- 36-242705
- Exp. 7/26/2023
- 36-251733
Distribution
Distributed nationwide across the United States.
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