Class I - Dangerous
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Betamethasone 6 mg/mL Injectable, 5 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
Dexamethasone 10 mg/mL Injectable, 2 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
Procaine 1% Injectable, 100 mL and 250 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
Testosterone Cypionate 200 mg/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
Lack of Assurance of Sterility: Confirmed report of leaking in the primary container.
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.
MIC (Methionine, Inositol, and Choline) + B12 25/50/50mg/1000mcg/mL Injectable, 30 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.
Voltaren 1% Gel, 100 gm tube, Rx only, Dist By: Physicians Total Care, Tulsa OK 74146, Mfg By: Novartis Consumer Health, Parsippany, NJ 07054, NDC 54868-5965-00
Physicians Total Care
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Expiration Date; This recall is being initiated because the lot number and expiration date on the tube may not be legible.
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
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.
Lorazepam, 0.5 mg tablets, 100 count, RX only, Distributed by Major Pharmaceuticals, Livonia, MI. NDC 0904-6007-60
Legacy Pharmaceutical Packaging
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date: Lorazepam Lot # L-04009
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.