The Recall Desk

FDA (Drugs) recall action 72956

PD-Rx Pharmaceuticals, Inc. recalled 2 products on 2016-01-13

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
2016-01-13
Critical
0
Units
62,555

Why these products were recalled

cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.

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.

1–2 of 2

  • ModerateFDA (Drugs)··2016-01-13

    PD-Rx Pharmaceuticals Recalls Azithromycin 500 mg Tablets for cGMP Deviations

    PD-Rx Pharmaceuticals is recalling Azithromycin 500 mg tablets because the original manufacturer did not adequately investigate customer complaints, resulting in cGMP deviations.

    Product
    Azithromycin 500 mg tablets, Rx Only, packaged in a) 1 count, b) 2 count, c) 3 count, and d) 7 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127, Mfr: Wokhardt Ltd., Mumbai, India, NDC: a) 55289-274-79, b) 55289-274-02, c) 55289-274-03, d) 55289-274
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2016-01-13

    PD-Rx Recalls Azithromycin Tablets Due to Inadequate Complaint Investigation

    PD-Rx Pharmaceuticals is recalling 45,022 bottles of Azithromycin Tablets, USP, 250 mg, because the manufacturer did not adequately investigate customer complaints.

    Product
    Azithromycin Tablets, USP, 250 mg, Rx Only, packaged in a) 2 count and b) 4 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklahoma City, OK, 73127, Mfg: Wockhardt Ltd., Mumbai, India, NDC: a) 55289-964-02, b) 55289-964-04.
    Category
    Distribution
    0 states