Recalls / Class II
Class IID-1069-2023
Product
fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride, Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2081-1
- Affected lot / code info
- Lot: 17-271814, Exp. 8/6/2023; 17-271960, Exp. 8/8/2023; 17-272252, Exp. 8/13/2023; 17-272272, Exp. 8/14/2023; 17-272454, Exp. 8/16/2023; 17-272640, Exp. 8/20/2023; 17-272716, Exp. 8/21/2023.
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
- 295 bags
- 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-1069-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.