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FDA Warnings

Latest FDA Updates

Sterile Drug Products by Bella Pharmaceuticals: Recall - Lack of Sterility Assurance

Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.

Sterile Drug Products from Vital Rx, dba Atlantic Pharmacy and Compounding: FDA Alert - Lack of Sterility Assurance

UPDATED 08/18/2017. Recall issued for all lots of all compounded injectable prescription medications. Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death.

Zenith Alpha Thoracic Endovascular Graft by Cook Medical: Class I Recall - Potential Formation of Thrombus Inside Device

Thrombus may form inside the device after implantation. Thrombosis or occlusion may lead to serious adverse health consequences, including death.

Lorazepam Oral Concentrate, USP 2mg/mL by Amneal Pharmaceuticals: Recall - Misprinted Dosing Droppers

Significant probability of serious health consequences if more than the prescribed dose is dispensed, including: drowsiness causing trauma; increased anxiety; and risk of accidental injury to self or others.

Pravastatin Sodium Tablets by International Laboratories: Recall - Mislabeling

Common side effects of bupropion include: nausea, vomiting, dry mouth, headache, constipation, sweating, sore throat, diarrhea, dizziness, restlessness, blurry vision. Risk of allergic reactions are possible and could be life threatening.

Liquid Products Manufactured by PharmaTech and Distributed by Leader Brand, Major Pharmaceuticals, and Rugby Laboratories: Recall - Possible Product Contamination

Reports of B. cepacia infections in patients.

Liquid-filled Intragastric Balloon Systems: Letter to Healthcare Providers - Potential Risks

Five reports of unanticipated deaths that occurred from 2016 to present, in patients with liquid-filled intragastric balloon systems used to treat obesity.

Liquid Drug Products Manufactured by PharmaTech and Distributed by Rugby Laboratories and Possibly Other Companies: FDA Advisory - Not to Use

Advisory due to Burkholderia cepacia contamination and the potential for severe patient infection.

Balguti Kesaria Ayurvedic Medicine: FDA Warning - High Levels Of Lead

Exposure to lead can cause serious damage to the central nervous system, the kidneys and the immune system.

System CS100, CS100i and CS300 Intra-Aortic Balloon Pumps by Datascope: Field Correction - Potential Electrical Test Failure Code

UPDATED 08/04/2017. Class I Recall issued. Risk of failure of the device to initiate therapy.


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