Vancomycin IV Bags Recalled Over Sterility Assurance Concerns Nationwide
Central Admixture Pharmacy Services is recalling vancomycin 2 g/500 mL IV bags nationwide due to lack of sterility assurance. Validation data for decontamination cycles is not available.
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 an FDA Class II recall of an intravenous medication due to unvalidated sterilization processes, representing a theoretical contamination risk. No illnesses or hospitalizations have been reported. The score reflects that this is a risk-of-harm product where sterility is critical, though actual contamination has not been confirmed.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling vancomycin 2 g/500 mL added to 0.9% Sodium Chloride, 4 mg/mL IV bags. Approximately 5,588 bags have been distributed nationwide in the United States.
The recall is due to lack of assurance of sterility. The manufacturer lacks validation data for the decontamination cycles used in producing the medication, meaning there is no documented confirmation that sterilization procedures are adequate.
Intravenous medications require confirmed sterility to prevent infection. The unvalidated sterilization process represents a potential risk of contamination. Patients who received this product should consult their healthcare provider if they experience symptoms of infection such as fever or chills.
The recalled product
- Product
- vancomycin 2 g/500 mL added to 0.9% Sodium Chloride, 4 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6078-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Hazard
- sterility-assurance
- 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: 36-239526
- Exp. 7/12/2023
- 36-239993
- Exp. 7/13/2023
- 36-240796
- Exp. 7/17/2023
- 36-241982
- Exp. 7/24/2023
- 36-242696
- Exp. 7/26/2023
- 36-243161
- Exp. 7/27/2023
- 36-243954
- Exp. 7/31/2023
- 36-245534
- Exp. 8/2/2023
- 36-247885
- Exp. 8/10/2023
- 36-248977
- 36-249137
Distribution
Distributed nationwide across the United States.
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