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The Lead

Report: FDA Recalls Fell in Fourth Quarter of 2014

February 25, 2015 3:42 pm | by Andrew Szal, Editor, Pharmaceutical Processing | News | Comments

A recent report found that recalls of products overseen by the U.S. Food and Drug Administration fell during the final quarter of 2014 but the number of affected units increased.
 

Sagent Pharmaceuticals Initiates Voluntary Recall of Atracurium Besylate Injection

February 23, 2015 2:05 pm | News | Comments

Sagent Pharmaceuticals has announced the voluntary nationwide recall of two lots of Atracurium...

FDA Issues Warning as Peanuts Found in Cumin Spice

February 19, 2015 8:28 am | by MARY CLARE JALONICK, Associated Press | News | Comments

Hundreds of products are being pulled from store shelves after traces of peanut were found in...

Hospira Voluntarily Recalls Multiple Lots of Ketorolac Tromethamine Injection

February 11, 2015 11:49 am | News | Comments

Hospira has announced a voluntary recall of ketorolac tromethamine injection, USP in the United...

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Valeant Pharmaceuticals Recalls Virazole®

January 2, 2015 8:38 am | News | Comments

Valeant Pharmaceuticals is issuing a voluntarily recall of one lot of Virazole® (ribavirin powder for solution), 100 mL, 6g Vial, 4-pack to the user level. Inhalation of a non-sterile product with microbial contamination into the airways could increase the risk of respiratory infection.

Hospira Recalls Ten Lots of Mitoxantrone

December 24, 2014 10:46 am | News | Comments

Hospira has initiated a voluntary recall of 10 lots, identified below, of MitoXANTRONE (both human and veterinary), due to confirmed subpotency and elevated impurity levels.             

Baxter Recalls Two Lots of Sodium Chloride Injection

December 15, 2014 3:10 pm | News | Comments

Baxter announced it voluntarily initiated a recall in the United States of two lots of 0.9% Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container to the hospital/user level. The recall is being initiated as a result of two complaints (one per lot) of particulate matter that was identified as a fragment of the frangible from the vial adapter.

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Aurobindo Pharma Recalls Northstar Label Gabapentin Capsules, USP 300 mg Due to Complaints of Empty Capsules

November 24, 2014 3:04 pm | News | Comments

Aurobindo Pharma USA is voluntarily recalling lot GESB14011-A of Gabapentin Capsules, USP 300 mg 100-count bottles to the consumer level. The product lot has been found to contain some empty capsules.         

New Warning for Dietary Supplement Users

October 23, 2014 10:46 am | Videos | Comments

Researchers at Harvard found that two-thirds of dietary supplements that have previously been recalled still contain banned ingredients. Also, smoking may get in the way of recovering alcoholics.         

Study Finds Drugs Still in Recalled Supplements

October 22, 2014 8:58 am | by LINDSEY TANNER, AP Medical Writer | News | Comments

Dietary supplements containing potentially dangerous prescription drug ingredients may still be for sale even years after safety recalls, a study found. In supplements bought online, researchers detected hidden steroids, similar ingredients to Viagra and Prozac and a weight loss drug linked with heart attacks.

Packaging Error Prompts Recall of Naproxen Pills

October 21, 2014 11:48 am | News | Comments

A North Carolina company is recalling nearly 12,000 boxes of pain relief tablets sold at Dollar Tree stores because some cartons contain a different medication that could cause allergic reactions.         

Mylan Recalls Some Lots of Nitroglycerin Spray Used to Treat Angina

October 15, 2014 2:14 pm | by The Canadian Press | News | Comments

Some lots of the product, called Mylan-Nitro Sublingual Spray 0.4 mg Per Metered Dose, are potentially missing the dip tube, a part of the pump component. A missing dip tube could pose a problem with delivery of nitroglycerin to the patient.  

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Hospira Announces Voluntary Nationwide Recall of Certain Lots of Several Lifecare Products

October 15, 2014 8:44 am | News | Comments

Hospira has announced the voluntary recall of certain lots of several products in its LifeCare™ line of flexible intravenous solutions due to the potential for leakage.              

Oregon Compounding Centers Recalls Unexpired Sterile Products Due to Lack of Sterility Assurance

October 10, 2014 8:16 am | News | Comments

The company has not received any reports of product contamination or adverse events to date, but is issuing this voluntary recall out of an abundance of caution following a recent inspection which identified an issue with sterility assurance.  

Baxter Recalls One Lot of Potassium Chloride Injection

September 17, 2014 3:00 pm | News | Comments

Baxter International Inc. announced today it is voluntarily recalling one lot of Potassium Chloride Injection 10mEq per 100mL, product code 2B0826 to the hospital/pharmacy/nurse level. The recall is being initiated due to a labeling error on the shipping cartons in a single lot, which was identified by three customers.

Hospira Recalls One Lot of Heparin Sodium in 0.9% Sodium Chloride Injection

September 12, 2014 8:38 am | News | Comments

Hospira is initiating a voluntary nationwide user-level recall of one lot of Heparin Sodium, 1,000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9% Sodium Chloride Injection, 500 mL, NDC 0409-7620-03 Lot 41-046-JT with expiration date of 01NOV 2015. This action is due to one confirmed customer report of particulate in a single unit.

Pharmacy Creations Recalls Four Product Lots Due to Potential Non-Sterility

September 8, 2014 9:56 am | News | Comments

Pharmacy Creations has voluntarily recalled four product lots (see below) following testing results conducted by Front Range, Inc., its former independent testing laboratory, that indicated that the product lots may have the potential of not being sterile.

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Regeneca Worldwide Expands Voluntarily Recall of Regeneslim Appetite Control Capsules

September 2, 2014 9:04 am | News | Comments

Regeneca Worldwide a division of VivaCeuticals, Inc. Las Vegas, NV is expanding the voluntary nationwide recall of its RegeneSlim appetite control dietary supplement to include lot #823230415, lot #EX0616r 15813, Lot # EX0616R15814 and Lot #11414re5516 because FDA analysis confirmed the presence of DMAA.

Amgen Recalls Aranesp Prefilled Syringes in Several Countries Outside of the U.S. Due to the Presence of Visible Particulates

August 14, 2014 9:05 am | News | Comments

Amgen initiated a voluntary recall on June 26, 2014 for nine packaged lots of Aranesp (darbepoetin alfa) (500 mcg) prefilled syringes from non-U.S. distributors, wholesalers and a number of hospital pharmacies due to the potential presence of cellulose and/or polyester particles observed in a small number of syringes during a routine quality examination.

Regeneca Worldwide Recalls RegenESlim Appetite Control Capsules

August 8, 2014 8:31 am | News | Comments

Regeneca Worldwide a division of VivaCeuticals, Inc. Las Vegas, NV is conducting a voluntary nationwide recall of its RegenESlim appetite control dietary supplement from lot # EX0616R15814 and lot #11414RE5516 because FDA analysis confirmed the presence of DMAA. 

Cubist Pharmaceuticals Issues Voluntary U.S. Recall of Certain Lots of CUBICIN

August 6, 2014 8:29 am | News | Comments

Cubist Pharmaceuticals today announced it is voluntarily recalling certain lots of CUBICIN® (daptomycin for injection) to the user level due to the potential presence of glass particulate matter in vials produced by a contract manufacturer.  

BMS Issues Voluntary Nationwide Recall of COUMADIN® for Injection Due to Presence of Particulate Matter

June 30, 2014 1:40 pm | News | Comments

Bristol-Myers Squibb Company is voluntarily recalling six lots of COUMADIN® FOR INJECTION, 5 mg single-use vials in the U.S. This recall is a precautionary measure based on the company’s investigation of visible particulate matter found in a small number of COUMADIN FOR INJECTION unreleased samples.

Red Yeast Rice Recalled Due to Undeclared Lovastatin

June 25, 2014 8:16 am | News | Comments

Doctor’s Best is voluntarily recalling lot 3121005 (7379 bottles) of Red Yeast Rice dietary supplement, 600 mg Capsules, 120-count bottles to the retail level. Red Yeast Rice has been found to contain undeclared lovastatin, a previously approved drug indicated for the treatment of high cholesterol, making this an unapproved new drug.

Alexion Recalls Certain Lots of Soliris Due to Visible Particulate Matter

June 2, 2014 8:21 am | News | Comments

Alexion Pharmaceuticalstoday announced that it is initiating a voluntary recall of certain lots of Soliris® (eculizumab) 300 mg/30 mL concentrated solution for intravenous infusion that were manufactured using a process component during vial filling identified in the November 2013 recall to the hospital/user level.

Hospira Announces Voluntary Nationwide Recall Of One Lot Of Labetalol Hydrochloride Injection

May 19, 2014 8:52 am | News | Comments

Hospira will initiate a voluntary nationwide recall to the user level for one lot of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL) 20 mL Multidose Vial, NDC 0409-2267-20, Lot 36-225-DD, Expiration 12/01/2015. The recall is due to a confirmed customer report of embedded particulate within the glass vial and visible particles floating in the solution.

Cubist Pharmaceuticals Recalls One Lot of CUBICIN 500 mg in 10 mL Single Use Vials

April 18, 2014 2:45 pm | News | Comments

Cubist Pharmaceuticals is voluntarily recalling one lot of CUBICIN® (daptomycin for injection) to the user level due to the presence of particulate matter, reported via customer complaint and identified as glass particles, found in a single vial from this lot, produced by a contract manufacturer.

Hospira Recalls Seven Lots of Propofol Injectable Emulsion

April 18, 2014 2:36 pm | News | Comments

Hospira announced today that on April 2, 2014, it informed customers of a nationwide recall of seven lots of Propofol Injectable Emulsion, USP, to the user level due to a glass defect located on the interior neck of the vial, which was identified during a retain sample inspection where the glass vial contained visible embedded metal particulate. Free-floating metal particulates were also identified in vials upon further analysis

GSK Recalls Weight Loss Drug

March 28, 2014 9:11 am | by The Associated Press | News | Comments

GlaxoSmithKline is recalling the weight loss drug Alli after receiving reports of unknown pills and tablets in the bottles.                     

Shire Recalls One Batch of Gaucher Disease Drug

March 14, 2014 1:48 pm | News | Comments

Shire is recalling one batch of its Gaucher disease treatment Vpriv because particulate matter was discovered in some vials of the drug.                    

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