Class III · Low risk
Milrinone Lactate Injection
Failed Impurities/Degradation Specifications
Milrinone Lactate Injection 200 mcg
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Bags have the potential to leak.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
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.
Affected NDC
0409-2776-02
Compare with the code on your package — it is the most precise check available.
Drug: Milrinone
- Recalling firm
- Pfizer Inc.
- NDC code
- 0409-2776-02
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1486-2019 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Milrinone recalls
See all
Class II · Moderate risk
Milrinone
Lack of sterility assurance
Class II · Moderate risk
Milrinone Lactate Injection 200 mcg
Lack of Assurance of Sterility: Bags have the potential to leak.
Class II · Moderate risk
Milrinone Lactate in 5% Dextrose Injection
Lack of assurance of sterility: customer complaints received for the presence of leaks.
Class II · Moderate risk
Milrinone 200 mcg/mL in a) D5W-300 mL
Lack of Sterility Assurance
Other recalls by Pfizer Inc.
All 2019 recalls
Class II · Moderate risk
Dopamine HCl Inj.
Lack of Assurance of Sterility
Class II · Moderate risk
Vial Label: 8.4% Sodium Bicarbonate Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Vial Label: Epinephrine Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Levoxyl (levothyroxine sodium tablets, USP)
Subpotent drug
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