Breaking News

Teva Recalls Lot of Amikacin Sulfate

March 11, 2016

Potential presence of particulate matter identified as glass in one vial

Teva Pharmaceuticals has voluntary recalled of one lot of amikacin sulfate injection USP, 1 gram/4mL (250 mg/mL) vials due to the potential presence of particulate matter identified as glass in one vial. The recalled lot number is: 4750915.
If present in an intravenous drug, 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 if a critical organ is affected. To date, Teva has not received any reports of adverse events or complaints related to this recall.
Amikacin sulfate injection USP is used in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria and also staphylococcal infections. Amikacin sulfate injection is packaged in pharmacy bulk packages, containing ten 1 gram/4 mL (250 mg/mL) vials per shelf pack. Amikacin sulfate injection 250 mg/mL, 4 mL vials were distributed nationwide through wholesalers, retailers and pharmacies.
Teva has issued an Urgent Drug Recall Letter to their direct customers. Teva is arranging for impacted product to be returned to Inmar.

Related Packaging:

blog comments powered by Disqus
  • The Role of Value in Drug Pricing

    The Role of Value in Drug Pricing

    Keren Shani, Ryan Million, Trinity Partners ||October 11, 2016
    Exploring the trend of using frameworks and models to evaluate the value of a drug

  • CRO-Sponsor Partnerships

    CRO-Sponsor Partnerships

    Craig Morgan, Brand Development Director, goBalto Inc.||October 11, 2016
    10 tips for enabling better CRO and sponsor collaborations

  • The Human Parts of Mouse Models

    The Human Parts of Mouse Models

    Julia Schueler, Head of in vivo Operations, Oncotest, a Charles River company ||October 11, 2016
    The PDX model system has come back into focus