Recalls / Class II
Class IID-0969-2023
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
- Affected lot / code info
- 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; 36-251707, 36-251714, Exp. 8/29/2023; 36-255496, 36-255497, 36-255498, 36-255499, Exp. 9/7/2023; 36-256320, 36-256322, Exp. 9/12/2023.
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
- 6,782 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-0969-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.