Vancomycin IV bags recalled due to sterility assurance failure
Central Admixture Pharmacy Services is recalling 6,782 bags of vancomycin IV bags distributed nationwide due to lack of validation data for decontamination cycles, which compromises sterility assurance.
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 classified this as Class II. The source reports no illnesses or injuries. However, the hazard of lack of sterility assurance for an intravenous medication represents a significant risk of harm to patients. This meets the High criterion: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 6,782 bags of vancomycin 1.75g in 0.9% sodium chloride 500mL IV bags distributed nationwide. The product is identified by NDC 72196-7060-1 and includes multiple lot numbers with expiration dates from July 2023 through September 2023.
The recall is due to a lack of validation data for decontamination cycles used during product preparation. This validation failure means there is no assurance that these IV bags meet sterility requirements.
Healthcare facilities and patients should stop use of the recalled lots immediately and contact their healthcare provider or pharmacist. Patients with questions may contact Central Admixture Pharmacy Services, Inc. at 2200 South 43rd Avenue, Phoenix, AZ 85043.
The recalled product
- Product
- vancomycin 1.75g added to 0.9% sodium chloride 500mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7060-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Intravenous
- Hazard
- sterility-failure
- 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: 36-239519
- 36-239518
- Exp. 7/12/2023
- 36-239992
- Exp. 7/13/2023
- 36-240844
- Exp. 7/18/2023
- 36-241983
- Exp. 7/24/2023
- 36-243151
- Exp. 7/27/2023
- 36-243950
- Exp. 7/31/2023
- 36-245538
- 36-245544
- Exp. 8/2/2023
- 36-247881
- Exp. 8/10/2023
- 36-251053
- Exp. 8/24/2023
Distribution
Distributed nationwide across the United States.
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