D-1487-2019 Class II Terminated

Recalled by Pfizer Inc. — New York, NY

Recall Details

Product Type
Drugs
Report Date
July 24, 2019
Initiation Date
July 9, 2019
Termination Date
October 27, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
280340 bags

Product Description

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.

Reason for Recall

Lack of Assurance of Sterility: Bags have the potential to leak.

Distribution Pattern

United States, PR, and Guam

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.