FDA announces AccessGUDID data update
Editor's Note The Food and Drug Administration announced that new data elements will be available on AccessGUDID, in the download files and in the APIs, as of April 2. Data for FDA Premarket Submission Number and FDA Premarket Supplement Number will not be provided until this summer. The FDA is…
FDA: Class I recall of BD Vacutainer® blood collection tubes
Author's Note The Food & Drug Administration on March 23 announced the Class I recall of Becton Dickinson (BD) Vacutainer® EDTA (ethylenediaminetetraacetic acid) blood collection tubes with lavender, tan, pink, and green rubber tube stoppers. Class I recalls are the most serious. The recall was initiated because of a chemical…
FDA: Recall of methylprednisolone sodium succinate for injection
Editor's Note The Food and Drug Administration (FDA) on March 6 announced the recall by Sagent Pharmaceuticals (Schaumburg, Illinois) of 10 lots of methylprednisolone sodium succinate for injection, USP, 40 mg, 125 mg, and 1 g. The recall was initiated because of the discovery of high out of specification impurity…
FDA: Hospira recalls three lots of hydromorphone HCL injection
Editor's Note The Food & Drug Administration (FDA) on March 5 announced the recall by Hospira (Lake Forest, Illinois) of three lots of hydromorphone HCL injection, USP Cll 10 mg/mL, 1 mL in 2 mL single dose vials. The recall was initiated because units from these lots may be empty…
FDA issues warning for compounded drugs from Cantrell Drug Company
Editor's Note The Food & Drug Administration (FDA) on March 2 issued a warning for healthcare professionals not to use drug products produced by Cantrell Drug Company (Little Rock, Arkansas), including opioids and other drugs intended for sterile injections. The FDA is concerned about serious deficiencies in Cantrell’s compounding operations,…
FDA: Class I recall of certain Medtronic ICDs, CRT-Ds
Editor's Note The Food & Drug Administration (FDA) on February 27 classified the recall by Medtronic of certain Implantable Cardiovert Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) as Class I, the most serious. The recall was initiated because of a defect in the manufacturing process. The defect causes an…
FDA: Hospira recalls four lots of Labetalol Hydrochloride
Editor's Note The Food and Drug Administration (FDA) on February 23 announced the recall by Hospira Inc (Lake Forest, Illinois) of three lots of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL vial (NDC 0409-2267-25), and one lot of Labetalol Hydrochloride Injection, USP, Novaplus (NDC 0409-2267-25). The recall was initiated because…
FDA: Class I recall of HeartStart MRx Defibrillator
Editor's Note The Food & Drug Administration (FDA) on February 9 classified the recall by Philips Electronics (Andover, Massachusetts) of its HeartStart MRx Defibrillator as Class I, the most serious. The recall was initiated because of micro cracks in the gas discharge tube that allow internal gasses to escape and…
FDA: Class I recall of AirLife Humidification Chamber, Heated Breathing Circuit Kits
Editor's Note The Food and Drug Administration (FDA) on January 31 classified the recall by Vyaire Medical (Mettawa, Illinois) of its AirLife Humidification Chamber and Heated Breathing Circuit Kits as Class I, the most serious. The recall was initiated because of a manufacturing error that may cause parts of the…
FDA: AuroMedics recalls one lot of Levofloxacin
Editor's Note The Food & Drug Administration (FDA) on January 18 announced the recall by AuroMedics (East Windsor, New Jersey) of one lot of Levofloxacin in 5% Dextrose Injection 250 mg/50 mL in a single-use flexible container (NDC 55150-243-46, Lot CLF160003, Expiry date May 2018). The product has been found…
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