FDA sends letter to healthcare providers on neurovascular stents
Editor's Note The Food and Drug Administration (FDA) on May 8 sent a letter to healthcare providers that included recommendations on the use of neurovascular stents for stent-assisted coiling in the treatment of unruptured brain aneurysms. The FDA has received reports associated with these devices that suggest events of peri-procedural…
FDA: AuroMedics recalls two lots of Ampicillin and Sulbactam for Injection
Editor's Note The Food and Drug Administration (FDA) on May 8 announced the recall by AuroMedics Pharma (Windsor, New Jersey) of two lots of Ampicillin and Sulbactam for Injection USP, 3 g single-dose vials. The recall was issued because of customer complaints of the presence of red particulate matter in…
FDA approves firmware update for Abbott ICDs, CRT-Ds
Editor's Note The Food and Drug Administration (FDA) on April 17 announced that it had approved a firmware update that is now available for certain Abbott (formerly St Jude Medical) implantable cardiac devices (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The update is a corrective action (recall) to reduce the…
FDA alert: Coastal Meds recalls all sterile products
Editor's Note The Food and Drug Administration (FDA) on April 13 announced the recall by Coastal Meds (Biloxi, Mississippi) of all nonexpired products marketed as sterile because of visible particles in some of the drug vials for injection and poor sterile production practices. The FDA on April 5 requested the…
FDA: Premier Pharmacy Labs recalls certain sterile injectable products
Editor's Note The Food and Drug Administration (FDA) on April 12 announced the recall by Premier Pharmacy Labs (Weeki Wachee, Florida) of certain lots of sterile injectable products because of a potential lack of sterility assurance. The products include morphine sulfate (2 mg/mL and 3 mg/mL), hydromorphone HCL 1 mg/mL,…
FDA: Recall of Acrodose Plus and PL systems by Haemonetics
Editor's Note The Food and Drug Administration (FDA) on April 13 announced the recall by Haemonetics (Braintree, Massachusetts) of certain lots of its Acrodose Plus and PL Systems because the company has received reports of low pH readings for platelets stored in CLX HP bags. In some instances the drop…
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…
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