Recalls / Class II
Class IID-1486-2019
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.
- Affected lot / code info
- Lot #s: 86-615-KL, Exp. 1FEB2020; 87-701-KL, Exp. 1MAR2020; 90-114-KL, Exp. 1JUN2020
Why it was recalled
Lack of Assurance of Sterility: Bags have the potential to leak.
Recalling firm
- Firm
- Pfizer Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 E 42nd St, N/A, New York, New York 10017-5703
Distribution
- Quantity
- 58200 bags
- Distribution pattern
- United States, PR, and Guam
Timeline
- Recall initiated
- 2019-07-09
- FDA classified
- 2019-07-12
- Posted by FDA
- 2019-07-24
- Terminated
- 2021-10-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1486-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.