The Recall Desk

FDA (Drugs) recall action 65953

Specialty Compounding, LLC recalled 2 products on 2014-11-05

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
2014-11-05
Critical
1
Units
—

Why these products were recalled

Lack of Assurance of Sterility

Non Sterility: Microbial contamination

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

1–2 of 2

  • CriticalFDA (Drugs)··2014-11-05

    FDA Recalls Calcium Glucosate Injection Due to Microbial Contamination

    Specialty Compounding, LLC is recalling Calcium Gluconate 2 gm in 100 mL Sodium Chloride 0.9% for Injection due to non-sterility and microbial contamination.

    Product
    CALCIUM GLUCONATE 2 gm (PF) PRESERVATIVE FREE in 100 mL Sodium Chloride 0.9% for Injection, Rx Only Manufactured by Specialty Compounding, 211 S. Bell Blvd, Cedar Park, TX 78613
    Category
    Distribution
    0 states