Recalls / Class II
Class IID-1076-2023
Product
rocuronium, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6010-1
- Affected lot / code info
- Lot: 17-270519, Exp. 7/16/2023; 17-270605, Exp. 7/17/2023; 17-270684, Exp. 7/18/2023; 17-270898, Exp. 7/20/2023; 17-271074, Exp. 7/24/2023; 17-271324, Exp. 7/27/2023; 17-271603, Exp. 8/1/2023; 17-271670, Exp. 8/2/2023; 17-272529, Exp. 8/17/2023; 17-272883, Exp. 8/23/2023; 17-273235, 17-273245, 17-273262, 17-273263, 17-273264, Exp. 8/30/2023; 17-273418, Exp. 9/3/2023; 17-273768, 17-273788, Exp. 9/7/2023; 17-274022, 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
- 10,065 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-1076-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.