Safety Alerts & Recalls
The Food and Drug Administration (FDA) has announced that new, validated manual reprocessing instructions have been issued by Olympus for the TJF-Q180V endoscopic retrograde cholangiopancreatography (ERCP) endoscopes (duodenoscopes) after reports of multi-drug resistant bacterial infections in patients in patients who have undergone ERCP with reprocessed duodenoscopes, even when the manufacturer reprocessing instructions are correctly followed.
The Food and Drug Administration (FDA) is recommending that manufacturers stop using the labels "latex-free" or "does not contain latex" due to the scientific inaccuracy of these claims.
The ASHP and ISMP have issued a National Alert for Serious Medications Errors regarding potentially dangerous mix-ups of neostigmine injection and phenylephrine injection.
The FDA stated the study results were inconclusive regarding the investigation of two deaths following the injection of Zyprexa Relprevv (olanzapine pamoate; Eli Lilly) from June 2013.
The FDA has issued a new safety warning regarding cases of serious and life-threatening symptomatic bradycardia as well as one case of fatal cardiac arrest following the co-administration of amiodarone with either Harvoni (ledipasvir and sofosbuvir fixed-dose combination; Gilead Sciences) or with Sovaldi (sofosbuvir; Gilead Sciences) in combination with another direct-acting antiviral (DAA).
Micro Labs announced a voluntary recall of 54,096 bottles of Simvastatin Tablets due to failed impurities/degradation specifications.
Hospira has announced a voluntary recall of one lot of Lactated Ringer's Irrigation 3000mL following a confirmed customer report of several dark, fibrous particulate floating within the solution of the primary container.
The Food and Drug Administration (FDA) is warning consumers to not buy or use Diablos Eca Fire Caps, Stiff Nights, La Pepa Negra, and Herb Viagra, which are marketed for sexual enhancement.
The FDA is warning consumers to not buy or use Black Mamba Hyperrush, Lean Body Extreme, and Natural Max Slimming weight loss supplements.
UltraZx Labs announced a voluntary recall of all lots of UltraZx, dietary supplements promoted for weight loss, due to the presence of undeclared ingredients.
- New Duodenoscope Cleaning Instructions Issued for Reprocessing Procedure
- Educating Clinicians on Safe Opioid Prescribing Part of New HHS Program
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- NIH: HIV Can Evolve, Replicate in Brain During Early Infection
- Comparing Roseroot Herb, Sertraline for MDD Treatment