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FDA Warnings

Latest FDA Updates

Varubi (rolapitant) Injectable Emulsion: Health Care Provider Letter - Anaphylaxis and Other Serious Hypersensitivity Reactions

Symptoms of anaphylaxis can include wheezing or difficulty breathing; swelling of the face or throat; hives or flushing; itching; abdominal cramping, abdominal pain or vomiting; back pain or chest pain; hypotension or shock.

Feeding Tube Placement Systems: Letter to Health Care Providers - Reports of Pneumothorax Events

CORRECTION to January 11, 2018 letter. Reported pulmonary events required urgent intervention, including needle decompression or chest tube placement.

Becton-Dickinson (BD) Syringes Used to Store Compounded or Repackaged Drugs: FDA Alert - Problematic Rubber Stoppers Replaced

General use BD syringes are cleared for immediate use in fluid aspiration and injection, but not for use as a closed container storage system for drug products.

Certitude Delivery System by Edwards Lifesciences: Class I Recall - Mold Overflow Defect Which May Obstruct Blood Flow

An embolism could obstruct blood flow to critical organs, leading to serious injury and/or a need to surgically extract the overflow material from the patient. Severe neurologic, cardiac, limb, renal, or gastrointestinal injury may result.

Prescription Opioid Cough and Cold Medicines: Drug Safety Communication - FDA Requires Labeling Changes

Risks of slowed or difficult breathing, misuse, abuse, addiction, overdose, and death with these medicines outweigh their benefits in patients younger than 18.

Clopidogrel Tablets USP, 75 mg by International Laboratories: Recall - Product Mislabeling

Missed doses of Clopidogrel increases the risk of heart attack and stroke which can be life threatening.

Ampicillin and Sulbactam for Injection USP 1.5 g/vial by Auromedics: Recall - Presence of Glass Particles in Vial

Administration of glass particulate may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening.

Compounded Sterile Products by PharMEDium Services: 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.

Reprocessed Agilis Steerable Introducer Sheath by Sterilmed: Class I Recall - Improper Seal of Sheath Hub

Improper seals can allow blood to leak through the hub, cause the cap to fall off during the procedure, or can create a difference in pressure that allows air into the circulatory system (air embolism).

Linezolid Injection by Auromedics Pharma: Voluntary Recall 600mg/300mL flexible bags- Due to Presence White Particle Matter That Has Been Identified as Mold

Use of a non-sterile injectable product could result in fatal infections in a broad array of patients.


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