FDA Drug Recalls

Recalls / Class II

Class IID-1064-2023

Product

morphine in 0.9% sodium chloride, 1 mg/1 mL, (1 mg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2040-1

Affected lot / code info
Lot: 17-270804, Exp. 7/19/2023; 17-271108, Exp. 7/25/2023; 17-271496, Exp. 7/31/2023; 17-271844, Exp. 8/6/2023; 17-272045, Exp. 8/9/2023; 17-272288, Exp. 8/14/2023.

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
1,699 syringes
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-1064-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.