The Recall Desk

FDA (Drugs) recall action 92081

PD-Rx Pharmaceuticals, Inc. recalled 5 products on 2023-05-10

The FDA (Drugs) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2023-05-10
Critical
0
Units
1,488

Why these products were recalled

CGMP deviations.

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.

1–5 of 5

  • ModerateFDA (Drugs)··2023-05-10

    Drug Recall: Glimepiride 4 mg for Manufacturing Practice Deviations

    PD-Rx Pharmaceuticals is recalling 186 bottles of Glimepiride USP 4 mg due to manufacturing deviations. Patients using this medication should contact their healthcare provider to verify if their supply is affected.

    Product
    Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0587-90
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2023-05-10

    Drug Recall: Montelukast Sodium Tablets Due to Manufacturing Deviations

    PD-Rx Pharmaceuticals has recalled 352 bottles of Montelukast Sodium USP 10 mg tablets distributed nationwide due to manufacturing process deviations. This was a voluntary recall by the firm.

    Product
    Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0762-30
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2023-05-10

    Simvastatin 40 mg recalled nationwide for manufacturing quality deviations

    PD-Rx Pharmaceuticals voluntarily recalled Simvastatin 40 mg due to manufacturing quality issues. The recall affects 393 bottles distributed nationwide, with affected lot expiration dates ranging from May 2023 to April 2024.

    Product
    Simvastatin USP 40 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottle (NDC 43063-0726-30) b) 90 count-bottle (NDC 43063-0726-90)
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-05-10

    Drug recall: Simvastatin 20 mg due to manufacturing control deviations

    PD-Rx Pharmaceuticals is voluntarily recalling 520 bottles of Simvastatin USP 20 mg nationwide due to manufacturing process quality control deviations. No adverse events have been reported.

    Product
    Simvastatin USP 20 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottles (NDC 43063-008-30), b) 90 count-bottles (NDC: 43063-0008-90)
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2023-05-10

    Simvastatin USP Tablets Recalled Due to Manufacturing Quality Deviations

    PD-Rx Pharmaceuticals is recalling Simvastatin USP 10 mg tablets due to manufacturing quality deviations. The recall affects 37 bottles distributed nationwide.

    Product
    Simvastatin USP, 10 mg, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottle (NDC 43063-0727-30) b) 90 count-bottle (NDC 43063-0727-90)
    Category
    Distribution
    0 states