The Recall Desk

FDA (Drugs) recall action 81810

Promise Pharmacy, LLC recalled 51 products on 2019-02-20

The FDA (Drugs) publishes a recall like this one as 51 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 51 pages.

Products
51
Announced
2019-02-20
Critical
0
Units
9,094

Why these products were recalled

Lack of sterility assurance.

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.

51–51 of 51

  • SevereFDA (Drugs)··2019-02-20

    Promise Pharmacy Recalls Leucine/Isoleucine/Valine Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling Leucine/Isoleucine/Valine injection vials due to a lack of sterility assurance. The affected products were distributed nationwide.

    Product
    Leucine/Isoleucine/Valine injection, 10mg/10mg/5mg/mL/mL, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Distribution
    0 states
Promise Pharmacy, LLC recalled 51 products on 2019-02-20 · The Recall Desk