Recalls / Class II
Class IID-0950-2023
Product
vancomycin 1.25 g/250 mL added to dextrose 5%, 5 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix AZ 85043, NDC: 72196-6073-1
- Affected lot / code info
- Lot: 36-245562, Exp. 8/2/2023; 36-254425, Exp. 9/5/2023; 36-255129, Exp. 9/6/2023; 36-238965, Exp. 7/10/2023; 36-256041, Exp. 9/11/2023; 36-241129, 36-241130, Exp. 7/19/2023; 36-241438, Exp. 7/20/2023; 36-242703, Exp. 7/26/2023; 36-243163, 36-243164, Exp. 7/27/2023; 36-251724, 36-251727, Exp. 8/29/2023.
Why it was recalled
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Recalling firm
- Firm
- Central Admixture Pharmacy Services, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2200 S 43rd Ave, N/A, Phoenix, Arizona 85043-3909
Distribution
- Quantity
- 4824 bags
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-07-14
- FDA classified
- 2023-08-01
- Posted by FDA
- 2023-08-09
- Terminated
- 2025-03-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0950-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.