Recalls / Class II
Class IID-1054-2023
Product
fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-3
- Affected lot / code info
- Lot: 17-271133, 17-271155, Exp. 7/25/2023; 17-271568, 17-271569, Exp. 8/1/2023; 17-271741, 17-271762, Exp. 8/3/2023; 17-272051, Exp. 8/9/2023; 17-272227, Exp. 8/13/2023; 17-272343, Exp. 8/15/2023; 17-272799, Exp. 8/22/2023; 17-273173, Exp. 8/29/2023; 17-273495, Exp. 9/4/2023.
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
- 2,082 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-1054-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.