Apotex Corp. is voluntarily recalling 36 lots of Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial and 4.5 gram/vial strengths, to the consumer/user level. The Piperacillin and Tazobactam for Injection have been found to contain elevated levels of impurities that may result in decreased potency. The affected product is manufactured by Hospira Inc., a Pfizer Company and distributed in the US market by Apotex Corp.
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Sugarfina, Inc. Issues Allergen Labeling Alert for Undeclared Eggs in Sugar Cookies Product
Sugarfina, Inc. is recalling its Sugar Cookies product because the label does not declare that this product contains egg. People who have allergies or severe sensitivities to eggs run the risk of serious or life-threatening allergic reaction if they consume this product.
FDA expands approval of Gilenya to treat multiple sclerosis in pediatric patients
FDA approves Gilenya (fingolimod) to treat multiple sclerosis MS in children age 10 and older. This is the first FDA approval of a drug to treat MS in pediatric patients
Statement from FDA Commissioner Scott Gottlieb, M.D., on the Trump Administration’s plan to lower drug prices
Statement from FDA Commissioner Scott Gottlieb, M.D., on the Trump Administration’s plan to lower drug prices
FDA warns more companies to stop misleading kids with e-liquids that resemble kid-friendly foods as part of Youth Tobacco Prevention Plan
FDA warns more companies to stop misleading kids with e-liquids that resemble kid-friendly foods as part of Youth Tobacco Prevention Plan
FDA seeks permanent injunctions against two stem cell clinics
FDA is seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval
FDA Investigates Multistate Outbreak of B. cepacia Complex Linked to Medline Remedy Essentials No-Rinse Cleansing Foam (FDA Announcement)
FDA Investigates Multistate Outbreak of B. cepacia Complex Linked to Medline Remedy Essentials No-Rinse Cleansing Foam (FDA Announcement)
Auromedics Pharma LLC Issues Voluntary Nationwide Recall of Product
East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling two lots of Piperacillin and Tazobactam for injection, USP 3.375 g (Piperacillin Sodium equivalent to 3 g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of Tazobactam USP. Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital level. The products have been found to contain particulate matter, visible only after reconstitution that was confirmed to be glass within the vial.
FDA permits marketing of new endoscopic device for treating gastrointestinal bleeding
FDA permits marketing of new endoscopic device for treating gastrointestinal bleeding
Auromedics Pharma LLC Issues Voluntary Nationwide Recall of Ampicillin and Sulbactam For Injection USP 3 Grams Due to The Presence of Visible Particulate Matter
AuroMedics Pharma LLC is voluntarily recalling two lots of Ampicillin and Sulbactam for Injection USP, 3 grams*/ Single-Dose vial, to the hospital/user level. The recall has been initiated due to customer complaints of the presence of red particulate matter in the product that is believed to be red rubber particles from the manufacturing process of the active ingredients.