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.
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 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.
- Affected units
- 3,980
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.
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.
See all 95 products in this recall →Related recalls
Same manufacturer · Central Admixture Pharmacy Services, Inc.
See all →- ModeratePediatric TPN Bags Recalled for Incorrect Formulation
FDA (Drugs) · 2026-08-12
- SeverePediatric Total Parenteral Nutrition Bag Recalled for Incorrect Formulation
FDA (Drugs) · 2026-07-01
- SevereInjectable Phenylephrine Solution Recalled Due to Particulate Matter Contamination
FDA (Drugs) · 2025-03-19
- HighEphedrine Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-10-11
- HighFentanyl injectable syringes recalled nationwide for sterility assurance failure
FDA (Drugs) · 2023-10-11
Same hazard · lack of sterility
See all →- SevereK.C. Pharmaceuticals Recalls Dry Eye Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Multiple Brands of Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Assurance Issues
FDA (Drugs) · 2026-09-30
- SevereGentle Eyes Lubricant Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
Similar recalls
- HighVancomycin Injectable Recalled for Lack of Sterility Validation
FDA (Drugs) · 2023-09-06
- HighDrug Recall: Vancomycin Injectable Lacks Sterility Assurance
FDA (Drugs) · 2023-05-31
- HighInjectable Vancomycin Admixture Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2023-05-31
- HighVancomycin Injectable Solution Recalled Due to Sterility Assurance Concerns Nationwide
FDA (Drugs) · 2023-05-31
- HighVancomycin Injectable Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2023-05-31
- HighVancomycin injection recalled due to sterility assurance concerns
FDA (Drugs) · 2023-05-31