Drug product
Calcium Chloride Preservative Free, 100mg/mL, a) 5 mL-vial, b) 30 ml-vial, Room Temperature, Tailor Made Compounding
D-1198-2022
Product summary
- Event
- Event 89909
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 138 vials
- Official record key
drug-enforcement:D-1198-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Batch #: a) 12072101A2, Exp 3/7/2022; 01042216A1, Exp 4/4/2022; 02142220A1, Exp 5/15/2022; b)12032129A2, Exp 3/3/2022; 02142220A1, Exp 5/15/2022; 03032213A1, Exp 6/1/2022; 03102214B, Exp 6/8/2022.
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility