Recalls / Class II
Class IID-1043-2023
Product
fentaNYL, 1250 mcg/25 mL, (50 mcg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-7
- Affected lot / code info
- Lot: 17-270664, Exp. 7/18/2023; 17-270886, Exp. 7/20/2023; 17-270976, 17-270989, Exp. 7/23/2023; 17-271335, Exp. 7/27/2023; 17-271572, Exp. 8/1/2023; 17-271747, Exp. 8/3/2023; 17-271808, Exp. 8/6/2023; 17-272023, Exp. 8/9/2023; 17-272203, Exp. 8/13/2023; 17-272718, Exp. 8/21/2023; 17-272797, Exp. 8/22/2023; 17-273157, Exp. 8/29/2023; 17-273507, Exp. 9/4/2023; 17-273766, Exp. 9/7/2023; 17-273862, Exp. 9/10/2023; 17-274052, Exp. 9/12/2023; 17-274208, 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
- 5,124 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-1043-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.