Drug product
Calcium Gluconate injectable, 10%, 50 ml Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
D-1157-2018
Product summary
- Event
- Event 80890
- Status
- Terminated
- Classification
- Class II
- Quantity
- 167 vials
- Official record key
drug-enforcement:D-1157-2018
Official wording
Reason: Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Code information: Lot #: 180626/10, Exp 24-Sep-18
Distribution pattern: Nationwide in USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility