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Recall Observatory FDA recall evidence

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

July 09, 2019

Class II

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

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility