Recalls / Class II
Class IID-0012-2024
Product
fentaNYL in 0.9% sodium chloride, 1,000 mcg/100 mL, (10 mcg/mL), 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-4
- Affected lot / code info
- Lot: 17-275314, 17-275319, 17-275320, 17-275324, 17-275327, 17-275328, 17-275349, Exp. 10/3/2023; 17-275510, 17-275531, 17-275536, 17-275541, 17-275548, Exp. 10/5/2023; 17-275656, Exp. 10/8/2023; 17-275714, Exp. 10/9/2023; 17-275766, 17-275786, 17-275787, 17-275802, Exp. 10/10/2023; 17-275918, 17-275926, Exp. 10/12/2023; 17-275951, Exp. 10/13/2023; 17-275966, 17-275975, 17-275977, Exp. 10/15/2023; 17-276103, Exp 10/17/2023.
Why it was recalled
Lack of assurance of sterility:
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
- 5,378 100 mL bags
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-09-21
- FDA classified
- 2023-10-04
- Posted by FDA
- 2023-10-11
- Terminated
- 2025-03-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0012-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.