FDA Approves New Treatment for HIV

The FDA approved Genvoya (a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older.

Sanofi Issues Voluntary Recall of Auvi-Q Due to Potential Inaccurate Dosage Delivery

Sanofi US has announced it is voluntarily recalling all Auvi-Q (epinephrine injection, USP), the FDA reports.

PharmaEngine Announces FDA Approves Merrimack's Onivyde

PharmaEngine, Inc. announced the FDA has approved Merrimack's Onivyde (irinotecan liposome injection) in combination with fluorouracil (5-FU) and leucovorin (LV) for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. In addition, the Taiwan FDA approved Onivyde/5-FU/LV for the same indication.

Onivyde is not indicated for use as a single agent, according to PharmaEngine..

Mislabeling Prompts Medline Industries, Inc. to Issue Voluntary Nationwide Recall of One Lot of Acetaminophen Tablets

Medline Industries, Inc. announced that it will initiate a voluntary nationwide recall of lot # 45810 of Acetaminophen tablets, 500mg, uncoated compressed tablets to the consumer level, reports the FDA. The Acetaminophen 500mg, Tab 100/BT (OTC20101) has been found to be mislabeled displaying “Acetaminophen 325mg” (OTC10101) instead of “Acetaminophen 500mg."

This lot was distributed nationwide from June 12, 2015 through Sept. 18, 2015.

Thoratec Issues Voluntary Device Correction

Thoratec Corporation issued a voluntary urgent medical mevice correction letter to all hospitals who have patients supported with the HeartMate II LVAS, reports the FDA. The letter is reminding those hospitals to monitor the expiration date of the backup battery contained within the HeartMate II "Pocket" System Controller, as specified in the product instructions for use. 

Mylan Launches Generic Unasyn for Injection

Mylan announced the U.S. launch of Ampicillin and Sulbactam for injection USP, 1.5 g/vial (1 g Ampicillin as the Sodium Salt and 0.5 g Sulbactam as the Sodium Salt), and 3 g/vial (2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt), and 15 g, Pharmacy Bulk Package, (10 g Ampicillin as the Sodium Salt and 5 g Sulbactam as the Sodium Salt), the generic version of Pfizer's Unasyn. 

Allergan Issues Voluntary Nationwide Recall on Specific Lots Of Refresh Lacri-Lube, Refresh P.M., FML, and Blephamide For Particulate Matter

Allergan announced that it is conducting a voluntary recall down to consumer level of specific lots of its Refresh Lacri-Lube 3.5g and 7g for dry eye, Refresh P.M.

FDA Cites Security Issue, Takes GUDID System Offline

The FDA’s Global Unique Identification Database (GUDID) was taken offline in early August due to a “security vulnerability,” reports sister publication Qmed.

Hartley Medical Issues Voluntary Recall of Prolotherapy with Phenol

Hartley Medical is voluntarily recalling three lots of Prolotherapy with Phenol, Injectable to the hospital/user level due to non-sterility concerns, reports the FDA. The product can be identified by its white label on each vial with the name “PROLOTHERAPY WITH PHENOL," and it was distributed in California and Nevada to pain clinics between May 15, 2015 through July 14, 2015. 

Unichem Pharmaceuticals Issues Recall of Hydrochlorothiazide Tablets

Unichem Pharmaceuticals (USA), Inc. (Unichem) is voluntarily recalling one lot of Hydrochlorothiazide Tablets 25 mg 1000-count bottle to the consumer level, reports the FDA. The recall has been initiated as a precautionary measure due to the identification of a Clopidogrel tablet found in a bottle of the product.

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