FDA Drug Recalls

Recalls / Class II

Class IID-0010-2024

Product

fentaNYL in 0.9% sodium chloride, 100 mcg/10 mL, (10 mcg/mL), 10 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2071-2

Affected lot / code info
Lot: 17-275476, Exp. 10/4/2023;17-275875, Exp. 10/11/2023

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
598 10 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-0010-2024. 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