Recalls / Class II
Class IID-1048-2023
Product
vecuronium, 10 mg/10mL, (1 mg/mL), 10 mL syringe, Rx only, PARALYZING AGENT, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6012-1.
- Affected lot / code info
- Lot: 17-273867, Exp.9/10/2023; 17-272606, Exp.8/20/2023; 17-272225, 8/13/2023; 17-272036, Exp. 8/9/2023; 17-271503, Exp. 7/31/2023; 17-271427, Exp. 7/30/2023; 17-271264, Exp. 7/26/2023; 17-270970, Exp.7/23/2023; 17-270784, Exp. 7/19/2023; 17-270674, Exp. 7/18/2023.
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
- 2,640 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-1048-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.