FDA and European Medicines Agency strengthen collaboration in pharmacovigilance area

The U.S. Food and Drug Administration and the European Medicines Agency (EMA) have set-up a new ‘cluster’ on pharmacovigilance (medicine safety) topics. Clusters are regular collaborative meetings between the EMA and regulators outside of the European Union, which focus on specific topic areas that have been identified as requiring an intensified exchange of information and collaboration. Building on the experience of previous regular videoconferences between the FDA and the EMA in this area and on the recent creation of the EMA’s Pharmacovigilance Risk Assessment Committee, this cluster will provide a forum for a more systematic and focused exchange of information on the safety of medicines.

Agila Specialties Private Limited Initiates Voluntary Nationwide Recall of 10 Lots of Etomidate Injection 2 mg/mL – 10 mL and 20 mL due to the Presence of Particulate Matter and/or Illegible and Missing Lot Number and/or Expiry Date

PITTSBURGH, PA-Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Agila Specialties Private Limited is conducting a voluntary nationwide recall to the hospital/user level of 10 lots of Etomidate Injection 2 mg/mL – 10 mL and 20 mL (see lot breakdown below). The 10 lots were manufactured by Agila Specialties Polska sp.zo.o in Warsaw, Poland.

Philips Respironics Initiates Recall of Trilogy Ventilator

On February 11, 2014, Philips Respironics initiated a voluntary recall to address a potentially defective component on the Trilogy Ventilator power management board, which could affect the function of the device. If this issue is not corrected it is possible that the ventilator may fail to deliver mechanical breaths and that the alarm functionality may be reduced to indicate ventilatory failure, resulting in serious adverse health consequences or death.

FDA approves Northera to treat neurogenic orthostatic hypotension

The U.S. Food and Drug Administration today approved Northera capsules (droxidopa) for the treatment of neurogenic orthostatic hypotension (NOH). NOH is a rare, chronic and often debilitating drop in blood pressure upon standing that is associated with Parkinson’s disease, multiple-system atrophy, and pure autonomic failure.

FDA initiates the Secure Supply Chain Pilot Program to enhance security of imported drugs

The U.S. Food and Drug Administration is announcing the initiation of the Secure Supply Chain Pilot Program to enhance the security of imported drugs. In August 2013, the FDA published a notice in the Federal Register (78 FR 51192) to solicit companies to voluntarily submit applications for participation in this two-year program. Thirteen prequalified companies have now been designated to take part, and will receive expedited entry for the importation of up to five selected drug products into the United States.

MyNicKnaxs, LLC. Issues a Voluntary Nationwide and International Recall of All weight loss formulas of: Magic Slim, Fruta Bio, SlimEasy, Super Fat Burning Bomb, Slim Xtreme, Meizi Evolution, Meizitang Strong Version Botanical Slimming, Jianfeijindan Activity Girl, and Japan Hokkaido Cangye Phamacy Co., LTD Japanese Chinese Formula pill for weight reduction.

MyNicKnaxs, LLC., located in Florida is announcing a recall of: Magic Slim, Fruta Bio, SlimEasy, Super Fat Burning Bomb, Slim Xtreme, Meizi Evolution, Meizitang Strong Version Botanical Slimming, Jianfeijindan Activity Girl, and Japan Hokkaido Cangye Phamacy Co., LTD Japanese Chinese Formula pill for weight reduction because these products contain undeclared active pharmaceutical ingredients: Phenolphthalein, sibutramine or a combination of both. At this time no illnesses or injuries have been reported to MyKnicKnaxs, LLC., in connection with these products.

Kettle Brand Voluntarily Recalls Limited Run of Bakes Sea Salt Potato Chips Due to Potential Milk Allergen

SALEM, Ore. — Kettle Brand is issuing a voluntary recall on a limited run of its 4-ounce Kettle Brand Bakes Sea Salt Potato Chips because of potential exposure to milk-based sour cream seasoning, a potential milk allergen not declared on the ingredient label. The brand is recalling 144 cases as a precaution. The product was distributed to 12 customer warehouses that supply retail stores nationwide. This is the only item impacted, and there have been no reports of illnesses or injury.
Read The Complete Story!