Class I - Dangerous
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Class I - Dangerous
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions
Hydroxyprogesterone 250 mg/mL Injectable, 4 mL, 6 mL,8 mL and 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
THE COMPOUNDING SHOP
Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class I - Dangerous
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class I - Dangerous
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class I - Dangerous
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class I - Dangerous
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class I - Dangerous
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class I - Dangerous
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class I - Dangerous
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class I - Dangerous
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class I - Dangerous
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class I - Dangerous
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class I - Dangerous
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
Class I - Dangerous
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class I - Dangerous
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Carnosine 5% Opth drop, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
THE COMPOUNDING SHOP
Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Methotrexate 25mg/mL Injectable, 10 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL
THE COMPOUNDING SHOP
Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class I - Dangerous
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.