Drug product
Lidocaine 2% HCl Inj, 500mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8091-1, code 7128580911.
D-0753-2023
Product summary
- Event
- Event 92253
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1516 bags
- Official record key
drug-enforcement:D-0753-2023
Official wording
Reason: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Code information: Lot # 37-870983, Exp 06/10/2023; 37-879653, 37-879654, Exp 07/16/2023; 37-883186, Exp 07/29/2023; 37-888533, Exp 08/20/2023; 37-893416, Exp 09/09/2023
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility