Drug product
Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection 40 mg/200 mL, 200 mL bag, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2776-02, Barcode (01)00304092776028.
D-1486-2019
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 83267
- Status
- Terminated
- Classification
- Class II
- Quantity
- 58200 bags
- Official record key
drug-enforcement:D-1486-2019
Official wording
Reason: Lack of Assurance of Sterility: Bags have the potential to leak.
Code information: Lot #s: 86-615-KL, Exp. 1FEB2020; 87-701-KL, Exp. 1MAR2020; 90-114-KL, Exp. 1JUN2020
Distribution pattern: United States, PR, and Guam
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility