Recalls / Class II
Class IID-1063-2023
Product
fentaNYL in 0.9% sodium chloride, 5000 mcg/250 mL, (20 mcg/mL), 250 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2074-1
- Affected lot / code info
- Lot: 17-271115, Exp. 7/25/2023; 17-271398, Exp. 7/30/2023; 17-272278, Exp. 8/14/2023; 17-272449, Exp. 8/16/2023; 17-272521, Exp. 8/17/2023; 17-272900, Exp. 8/23/2023; 17-273146, Exp. 8/29/2023; 17-273236, Exp. 8/30/2023; 17-273404, Exp. 9/3/2023; 17-273678, Exp. 9/6/2023; 17-273954, Exp. 9/11/2023; 17-274213, Exp. 9/14/2023.
Why it was recalled
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Recalling firm
- Firm
- Central Admixture Pharmacy Services Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7935 Dunbrook Rd Ste C, N/A, San Diego, California 92126-6322
Distribution
- Quantity
- 1,044 bags
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-07-17
- FDA classified
- 2023-08-03
- Posted by FDA
- 2023-08-09
- Terminated
- 2025-03-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1063-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.