[Posted 03/26/2015] AUDIENCE: Gastroenterology, Surgery, Nursing, Risk Manager, Biomedical Engineering, Patient ISSUE: Olympus has issued new, validated manual reprocessing instructions for the TJF-Q180V duodenoscope to replace those provided in the original labeling. The FDA has reviewed these new reprocessing instructions and the validation data as part of its ongoing review of the 510(k), and recommends…
Mammograms at Richard D. Adelman M.D. in Raleigh, North Carolina: FDA Safety Communication
[Posted 03/24/2015] AUDIENCE: Family Practice, OBGYN, Oncology, Radiology, Patient ISSUE: FDA is alerting patients who had mammograms at Richard D. Adelman, M.D., Family Medicine practice located in Raleigh, North Carolina, any time after August 24, 2012, about possible problems with the quality of their mammograms. The American College of Radiology (ACR) did a review of…
Hepatitis C Treatments Containing Sofosbuvir in Combination With Another Direct Acting Antiviral Drug: Drug Safety Communication
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Zyprexa Relprevv (olanzapine pamoate): Drug Safety Communication
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Over-the-Counter Asthma Products Labeled as Homeopathic: FDA Statement
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Lactated Ringer’s Irrigation, 3000mL by Hospira: Recall
[Posted 03/12/2015] AUDIENCE: Pharmacy, Risk Manager ISSUE: Hospira initiated a voluntary recall of one lot of Lactated Ringer’s Irrigation, 3000mL (NDC 0409-7828-08, Lot 40-008-JT; Expiry 1APR2016) to the user level (both human and veterinary) due to a confirmed customer report of several dark, fibrous particulates floating within the solution of the primary container. The particulate…
Treanda (bendamustine hydrochloride) Solution by Teva: FDA Statement – Not Compatible with Closed System Transfer Devices, Adapters, and Syringes Containing Polycarbonate or Acrylonitrile-Butadiene
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Chantix (varenicline): Drug Safety Communication
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Magnesium Sulfate in 5 Percent Dextrose Injection by Hospira: Recall
[Posted 03/06/2015] AUDIENCE: Pharmacy, Risk Manager ISSUE: Hospira announced a voluntary recall of one lot of Magnesium Sulfate in 5% Dextrose, Inj., USP, 10 mg/mL (NDC: 0409-6727-23, Lot 42-120-JT, Expiry 1DEC2015) to the user level due to confirmed customer reports of an incorrect barcode on the primary bag labeling. The barcode on the overwrap is…
Plum A+ and Plum A+3 Infusion Systems by Hospira: Class I Recall
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