D-1070-2023 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 9, 2023
- Initiation Date
- July 17, 2023
- Termination Date
- March 21, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,114 bags
Product Description
fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride, Total Volume = 100 mL, Total FentaNYL 200 mcg/100 mL, 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2082-1
Reason for Recall
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 17-274485, Exp. 9/19/2023; 17-270783, Exp. 7/19/2023; 17-270882, Exp. 7/20/2023; 17-271430, Exp. 7/30/2023; 17-271509, Exp. 7/31/2023; 17-272224, 17-272238, Exp. 8/13/2023; 17-272704, Exp. 8/21/2023; 17-273147, Exp. 8/29/2023.