Drug product
Modified del Nido Microplegia, packaged in 40 mL per syringe, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0219-1.
D-0681-2023
Product summary
- Event
- Event 92253
- Status
- Terminated
- Classification
- Class II
- Quantity
- 690 syringes
- Official record key
drug-enforcement:D-0681-2023
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 # 37-893821, Exp 04/28/2023; 37-894813, 37-894815, Exp 04/30/2023; 37-895489, 37-895490, Exp 05/05/2023; 37-897810, 37-897811, Exp 05/13/2023; 37-899585, Exp 05/20/2023
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility