Recalls / Class II
Class IID-1079-2023
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: 17-270539, Exp. 7/16/2023; 17-270981, Exp. 7/23/2023; 17-271167, Exp. 7/25/2023; 17-271337, Exp. 7/27/2023; 17-271827, Exp. 8/6/2023; 17-272214, Exp. 8/13/2023; 17-272536, 17-272555, Exp. 8/17/2023; 17-273424, 17-273432, Exp. 9/3/2023; 17-273476, Exp. 9/4/2023; 17-273882, Exp. 9/10/2023; 17-274044, Exp. 9/12/2023.
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
- 6,770 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-1079-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.