FDA Drug Recalls

Recalls / Class II

Class IID-0009-2024

Product

fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2071-1

Affected lot / code info
Lot: 17-275621, Exp. 10/8/2023; 17-275693, 17-275725, Exp. 10/9/2023

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
1,767 3 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-0009-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls