A routine annual reserve inspection at Biotest Pharmaceuticals Corporation discovered visible contaminants in a lot of BIVIGAM Immune Globulin Intravenous (Human) 10% Liquid, 100 mL sterile vial, Lot # 120016, expiration date: March 31, 2014. Inspectors at Biotest Pharmaceuticals Corporation in Boca Raton, Florida found the tainted medical product.
The Galveston drug recall attorneys at Denena Points, PC mention that Biotest has voluntarily recalled the affected product. And the FDA has classified the recall as urgent. All who received the BIVIGAM Immune Globulin Intravenous (Human) 10% Liquid should inspect the product for visible contaminants and return it to Biotest if it appears tainted.
Be aware of your risk. Now that officials are finally doing more inspections of drug and biologics processing facilities, our Galveston drug recall attorneys note that they’re finding more and more tainted medical products. The past month has seen a rash of drug recalls because inspectors found visible contaminants floating in bottled medications. In at least one instance, the visible contaminants were mold and the drug was from a compounding pharmacy that had previously been cited for safety issues.
Dozens of people had to die and hundreds became seriously ill from a fungal meningitis infection resulting from un-sterile manufacturing processes at a compounding pharmacy before the FDA and state pharmacy boards began taking action to step up inspections of drug and biologics processing facilities. Mold and fungal contaminants in tainted medical products that should be sterile are capable of causing very serious and even fatal complications in patients, as last fall’s fungal meningitis outbreak reveals.
Click the link to read about the recent FDA recall involving a dangerous mold tainted medical product from a compounding pharmacy. And don’t hesitate to contact us for a FREE, no obligation legal consultation if you’ve become ill because of a tainted medical product. Reach us at 281-369-4363 or through our online contact form.