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Recall Observatory FDA recall evidence

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

July 09, 2019

Class II

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

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility