Status
Terminated
Drug Enforcement D-1048-2023
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Classification
Class II
Report Date
August 9, 2023
Termination Date
March 21, 2025
Product Information
- Product description
- 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.
- Product quantity
- 2,640 Syringes
- Reason for recall
- Lack of assurance of sterility: Lack of validation data for sanitization cycles
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Central Admixture Pharmacy Services Inc
- Address
-
7935 Dunbrook Rd Ste C, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1048-2023
- Event ID
- 92752
- Recall initiation date
- July 17, 2023
- Center classification date
- August 3, 2023
- 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.
- More code info
- —