Drug product
Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection, 20 mg/100 mL, 100 mL bag, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2776-23, Barcode (01)00304092776233.
D-1487-2019
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 83267
- Status
- Terminated
- Classification
- Class II
- Quantity
- 280340 bags
- Official record key
drug-enforcement:D-1487-2019
Official wording
Reason: Lack of Assurance of Sterility: Bags have the potential to leak.
Code information: Lot #s: 85-516-KL; 85-517-KL, Exp. 1JAN2020; 86-601-KL; 86-603-KL; 86-618-KL, Exp. 1FEB2020; 87-707-KL, Exp. 1MAR2020; 91-205-KL, Exp. 1JUL2020; 92-306-KL, Exp. 1AUG2020.
Distribution pattern: United States, PR, and Guam
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility