Safety Alerts and Recalls

Safety Alerts & Recalls

New Duodenoscope Cleaning Instructions Issued for Reprocessing Procedure

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.

No More Latex-Free Claims, Recommends FDA

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.

Look-a-Like Injectables Prompt ASHP, ISMP to Issue National Alert

The ASHP and ISMP have issued a National Alert for Serious Medications Errors regarding potentially dangerous mix-ups of neostigmine injection and phenylephrine injection.

FDA Finishes Review of Patient Deaths Post-Zyprexa Relprevv 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.

FDA: Life-Threatening Interaction Possible Between Antivirals, Amiodarone

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).

Over 50,000 Bottles of Cholesterol Drug Recalled

Micro Labs announced a voluntary recall of 54,096 bottles of Simvastatin Tablets due to failed impurities/degradation specifications.

Mold Discovered in Lactated Ringer's Solution

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.

Multiple Undeclared Drugs Found in Sex Enhancement Pills

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.

FDA Analysis Reveals More Tainted Weight Loss Pills

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 Recalls Tainted Weight Loss Caps

UltraZx Labs announced a voluntary recall of all lots of UltraZx, dietary supplements promoted for weight loss, due to the presence of undeclared ingredients.