The Recall Desk

FDA (Drugs) recall action 83267

Pfizer Inc. recalled 2 products on 2019-07-24

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2019-07-24
Critical
0
Units
338,540

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • SevereFDA (Drugs)··2019-07-24

    Pfizer Recalls Milrinone Lactate Injection Bags Due to Sterility Concerns

    Pfizer is recalling 58,200 bags of Milrinone Lactate Injection in 5% Dextrose due to a lack of assurance of sterility and potential for bag leaks.

    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.
    Category
    Distribution
    2 states
  • SevereFDA (Drugs)··2019-07-24

    Pfizer Recalls Milrinone Lactate Injection Bags Due to Sterility Concerns

    Pfizer is recalling specific lots of Milrinone Lactate Injection bags because they may leak, compromising sterility.

    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.
    Category
    Distribution
    2 states