Vancomycin IV Bags Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 6,772 bags of vancomycin IV solution nationwide due to lack of assurance of sterility. Validation data for decontamination cycles is lacking.
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 is classified as FDA Class II. While no illnesses or injuries are reported in the source, this involves a sterility assurance issue for an intravenous medication—a high-risk product where contamination could cause serious harm. Per the rubric, risk-of-harm products where injury has not yet been reported are scored as 3 (High).
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 6,772 bags of vancomycin 1.5 g/500 mL added to 0.9% sodium chloride (3 mg/mL), Rx only. The product is manufactured by Central Admixture Pharmacy Services, Inc. located in Phoenix, Arizona.
The recall is due to a lack of assurance of sterility. Validation data for decontamination cycles is lacking, which creates uncertainty about whether the products have been adequately sterilized for safe intravenous use.
The affected product was distributed nationwide in the United States. Multiple lot numbers are included in the recall, with expiration dates ranging from July 10, 2023, through September 13, 2023.
The recalled product
- Product
- vancomycin 1.5 g/500 mL added to 0.9% sodium chloride, 3 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6176-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Hazard
- contamination-risk
- sterility-assurance
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: 36-238968
- 36-238985
- 36-238992
- 36-238998
- Exp. 7/10/2023
- 36-240784
- 36-240785
- 36-240786
- 36-240787
- Exp. 7/17/2023
- 36-240840
- 36-240842
- Exp. 7/18/2023
- 36-243157
- Exp. 7/27/2023
- 36-243953
- Exp. 7/31/2023
- 36-251050
- 36-251051
- 36-251059
Distribution
Distributed nationwide across the United States.
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