Recalls / Class II
Class IID-0015-2024
Product
fentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 50 mL, Total fentaNYL 75 mcg/50 mL, 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2080-2
- Affected lot / code info
- Lot: 17-275165, 17-275166, Exp. 10/1/2023; 17-275217, Exp. 10/2/2023; 17-275715, Exp. 10/9/2023; 17-276035, Exp. 10/16/2023; 17-276112, Exp. 10/17/2023
Why it was recalled
Lack of assurance of sterility:
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
- 895 50 mL syringes
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-09-21
- FDA classified
- 2023-10-04
- Posted by FDA
- 2023-10-11
- Terminated
- 2025-03-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0015-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.