Recalls / Class II
Class IID-1053-2023
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: 17-270685, Exp. 7/18/2023; 17-271343, Exp. 7/27/2023; 17-271490, Exp. 7/31/2023; 17-271578, Exp. 8/1/2023; 17-272293, Exp. 8/14/2023; 17-272786, Exp. 8/22/2023; 17-273575, Exp. 9/5/2023.
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
- 1669 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-1053-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.