Sagent Pharmaceuticals Initiates a Nationwide Voluntary Recall of Atracurium Besylate Injection

FDA-Recall-MedSchaumburg, ILLINOIS – Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of two lots of Atracurium Besylate Injection, USP, 50mg/5mL single-dose vials (NDC 25021-659-05) and four lots of Atracurium Besylate Injection, USP, 100mg/10mL multi-dose vials (NDC 25021-672-10) manufactured by Emcure Pharmaceuticals Ltd. and distributed by Sagent. Sagent has initiated this voluntary recall of Atracurium Besylate Injection, USP, 50mg/5mL and 100mg/10mL to the user level due to FDA observations pertaining to aseptic and GMP practices at the manufacturer’s site potentially impacting product sterility. Non-sterility of a drug administered via the intravenous route has the potential to result in infections, which could be fatal, especially in patients who are immunocompromised. Sagent has transferred the manufacture of this product to its own facility and this product manufactured at the Sagent facility will not be impacted by the recall.

Sagent is not aware of any adverse patient events resulting from the use of the subject product lots.

The lot numbers being recalled are VATA012, VATA015 (50mg/5mL) and VATB012, VATB013, VATB014, VATB017 (100mg/10mL) which were distributed to hospitals, wholesalers and distributors nationwide from February 2014 through February 2015. Atracurium Besylate Injection, USP, 50mg/5mL and 100mg/10mL is indicated, as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation, and is supplied in single-dose and multi-dose vials.

Customers are being notified by fax, email, FedEx, and/or certified mail that includes arrangements for return of all recalled product. Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return the recalled lots of product. Customers who may have further distributed this product have been requested to identify their customers and notify them at once of this product recall. The necessary form by which to document this information as well as other information regarding this recall is available at www.Sagentpharma.comdisclaimer icon.

Any questions about returning unused product should be directed to the customer call center at (866) 625-1618 M-F 8am-7pm CST. Healthcare workers who have medical questions about Atracurium Besylate Injection, USP may contact Sagent Medical Affairs (866-625-1618, Option 3) M-F 8am-5pm CST.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Chicago Bar Offers Free Drink for Votes Against Romney

BreitBart News

A Chicago Bar called “Rocks” is currently offering free drinks to voters at their election-night party. The above photo of the flyer for the bar makes light of the Chicago way, of voting “early and often, (As long as it isn’t for Romney).”

The bar clearly promotes Barack Obama, with the Obama logo appearing in the “O” of this instance of the bar’s name “Rocks.” More importantly, regardless of whom you interpret the sign to endorse, the bar is offering a free beer of the month to those that bring in their voting receipt.

What’s the problem? In Illinois, it’s against the law.

Read more at BreitBart

Tonya Reaves, Planned Parenthood and the art of downplaying a ‘tragedy’

As reported Tuesday by ABC News, the family of 24-year-old Tonya Reaves – the Chicago woman who died after hemorrhaging during an abortion at a Planned Parenthood clinic — has hired a lawyer to help them decide whether to take legal action.

“We’re just trying to get all the facts from the incident and determine what the best course of action is,” Corey Meyer, the family’s lawyer, said. “We’re still getting information.”

As reported Sunday by Fox News, Florida Republican Rep. Cliff Stearns and the anti-abortion Susan B. Anthony List have called for congressional oversight in the wake of Reaves’ death.

Apparently, when it comes to reporting abortion statistics – specifically in Chicago — much is overlooked.

Read more at Examiner.com