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Last updated on April 23, 2014 at 21:24 EDT

Latest Package insert Stories

2014-03-14 12:28:50

LEXINGTON, Massachusetts, March 14, 2014 /PRNewswire/ -- Shire Pharmaceuticals announced today the initiation of a voluntary recall in the United States of one batch, packaged into three lots, of VPRIV due to the presence of visible particulate matter, identified as stainless steel and barium sulfate. The particulate matter was found in a small number of vials in the three packaged lots of VPRIV. A Shire investigation identified the particulate matter root cause as the third...

2013-06-14 16:24:42

HORSHAM, Pa., June 14, 2013 /PRNewswire/ -- Amedra Pharmaceuticals LLC has announced re-launch of Adrenaclick®, a single-dose epinephrine auto-injector, for the emergency treatment of life threatening allergic reactions in people who are at risk for or have a history of anaphylaxis. Adrenaclick® will be available as a two-pack carton in both 0.15 mg and 0.30 mg strengths. For additional information about Adrenaclick® including prescribing information, please visit the...

2013-03-08 08:23:31

Clean lines and an instinctive user interface frames a practical prescription management tool for consumers on-the-go NEW YORK, March 8, 2013 /PRNewswire/ -- Drugs.com, the leading online clinical drug resource, today announced they have launched the Drugs.com Medication Guide, a mobile app to facilitate patient engagement in their own medication management. The "Drugs.com Medication Guide" app is now available as a free download on the popular iOS and Android mobile platforms....

2012-07-03 10:22:59

BEDFORD, Ohio, July 3, 2012 /PRNewswire/ -- Bedford Laboratories((TM)) today announced a nationwide voluntary hospital/user-level recall for: Product Description NDC Package Size Lot#/Expiration Date First Ship Date Last Ship Date ---...

2012-06-28 14:21:27

BEDFORD, Ohio, June 28, 2012 /PRNewswire/ -- Bedford Laboratories((TM)) today announced a nationwide voluntary hospital/user-level recall for: Vecuronium Bromide for Injection, 20 mg vial - NDC #55390-039-10 Lot 2067134 - Exp. Date 5/31/2013First Shipment - 8/8/2011Last Shipment - 11/9/2011 Please note: This recall is for lot 2067134 only. No other lots of Vecuronium Bromide for injection Preservative Free are subject to this voluntary recall. (Logo:...

2012-04-24 10:24:49

SHIRLEY, N.Y., April 24, 2012 /PRNewswire/ -- American Regent is conducting a nationwide voluntary recall to the Retail/Hospital level of the following product: Epinephrine Injection, USP, 1:1000, 1 mL AmpulesNDC #0517-1071-25 Lot #1395, Exp Date: July 2012 PLEASE NOTE: This recall, initiated on April 24, 2012 to the Retail/Hospital Level, is for lot #1395 only. No other lot or sizes of Epinephrine Injection, USP are subject to this voluntary recall. American Regent is undertaking this...

2012-04-02 14:21:55

SHIRLEY, N.Y., April 2, 2012 /PRNewswire/ -- American Regent is conducting a nationwide voluntary recall to the Retail/Hospital level of the following product: Cyanocobalamin Injection, USP, 1000 mcg/mL, 1 mL Vial NDC # 0517-0031-25 Lot # 1662, Exp Date: November, 2013Lot # 1679, Exp Date: November, 2013Lot # 1683, Exp Date: November, 2013 PLEASE NOTE: This recall, initiated on April 2, 2012 to the Retail/Hospital Level, is for these lot numbers only. No other lots or sizes of...

2012-03-14 20:27:07

A week ago, you started a new prescription medication for acne. Today, you feel dizzy and short of breath and have difficulty concentrating. Your symptoms are not listed in the package insert as possible side effects of the drug, but why else would you be feeling so odd? Unfortunately, there's no easy answer. Clinical trials are designed to show that a drug is safe and effective. But even the largest trials can't identify irksome or even dangerous side effects experienced by only a tiny...

2012-01-10 14:41:00

BEDFORD, Ohio, Jan. 10, 2012 /PRNewswire/ -- Bedford Laboratories(TM) today issued updated guidance on the following nationwide voluntary product recalls originally issued on August 2, 2011: Polymyxin B for Injection USP, 500,000 Units per vial - NDC #55390-139-10Lot 1942980 - Exp. Date August 2013 and Lot 1895027 - Exp. Date June 2013 Vecuronium Bromide for Injection, 10 mg per vial - NDC #55390-037-10Lot 1865067 - Exp. Date May 2012 Vecuronium Bromide for Injection, 20...

2011-12-06 11:28:00

Includes labeling revisions for both drugs SILVER SPRING, Md., Dec. 6, 2011 /PRNewswire-USNewswire/ -- The approval of changes to the Risk Evaluation and Mitigation Strategies (REMS) for both Nplate (romiplostim) and Promacta (eltrombopag) was announced by the U.S. Food and Drug Administration. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) An FDA-initiated review of the current information has determined that while safety risks for both Nplate and Promacta still exist,...