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Latest Adverse effect Stories

2014-07-18 20:21:41

TEMPLE, Texas, July 18, 2014 /PRNewswire/ -- Unique Pharmaceuticals, Ltd., ("Unique" or "the Company") today announced a voluntary nationwide recall of all sterile drug preparations compounded by the outsourcing facility that have not reached the expiration date listed on the products. Unique is initiating the recall due to FDA's concerns associated with Unique's compounding facilities and compounding processes that FDA contends present a lack of sterility assurance and were observed during...

2014-07-03 16:23:13

GREENSBORO, N.C., July 3, 2014 /PRNewswire/ -- ConvaTec has announced that the U.S. Food and Drug Administration (FDA) has classified the company's recently initiated voluntary global recall of Flexi-Seal(TM) CONTROL Fecal Management System (FMS) as a Class I recall. The FDA defines a Class I recall as a situation in which there is a reasonable probability that use of, or exposure to, a violative product will cause serious adverse health consequences or death. ConvaTec began notifying...

2014-06-13 23:03:11

According to a recently published research letter from JAMA, the severe cutaneous reactions are typically experienced following use of a broad array of prescription and over-the-counter medications. Port Washington, New York (PRWEB) June 13, 2014 Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective drugs is commenting on a study that reveals that the risk of repeat episodes of Stevens-Johnson syndrome (SJS) and toxic epidermal...

2014-05-23 16:24:17

OTTAWA, May 23, 2014 /CNW/ - The issue: Pharmascience Inc., in consultation with Health Canada, is recalling one lot of PMS-Losartan-HCTZ due to a labelling error on the blister pack (see photo below). The printed boxes of the product show the proper dosage "Losartan-HCTZ100/25mg," while some blisters or inner packages incorrectly say "Losartan-HCTZ 100/12.5mg." The product is packaged with 100/25mg tablets. Taking more of the drug than prescribed could have serious health...

2014-05-16 16:25:21

OTTAWA, May 16, 2014 /CNW/ - The issue: One lot of Lite Fit USA (Lot Number 13165, Exp. 05/17) is being voluntarily recalled in the U.S. after analysis by the U.S. Food and Drug Administration revealed the lot contains the undeclared prescription drug sibutramine. Lite Fit USA is not authorized for sale in Canada, but Health Canada has confirmed that this lot was imported and sold by the retail store Hoang Oanh Sandwich, 7178 St. Denis, Montreal, Québec. The affected lot may...

2014-05-01 08:34:23

FRAMINGHAM, Mass., May 1, 2014 /PRNewswire/ -- HeartWare International, Inc. (Nasdaq: HTWR), today issued a voluntary Urgent Medical Device Correction related to all HeartWare(®) Ventricular Assist System batteries, product codes 1650 and 1650-DE. In letters to clinicians and patients, the company reports an observed increase in complaints related to earlier-than-expected battery depletion and routine battery handling. HeartWare is providing information to assist patients and clinicians in...

2014-04-24 20:23:05

FRAMINGHAM, Mass., April 24, 2014 /PRNewswire/ -- HeartWare International, Inc. (Nasdaq: HTWR) today announced issuance of a clinician and patient reminder concerning the Urgent Medical Device Correction distributed to all of its clinical sites by the company in December 2013. The device correction discussed eight complaints that the locking mechanism of the driveline connector of the HeartWare(®) Ventricular Assist System had failed to engage and instructed clinicians to inspect patient...

2014-04-08 08:31:42

New submission based on positive Phase 3 data from the RESONATE(TM) trial RARITAN, N.J., April 8, 2014 /PRNewswire/ -- Janssen Research & Development, LLC ("Janssen") today announced the submission of a supplemental New Drug Application (sNDA) for IMBRUVICA(TM) (ibrutinib) to the U.S. Food and Drug Administration (FDA) by its collaboration partner Pharmacyclics, Inc. This regulatory submission is based on data from the Phase 3 RESONATE(TM) study in relapsed or refractory chronic...

2014-03-17 16:28:56

PLEASANTON, Calif., March 17, 2014 /PRNewswire/ -- On March 4, 2014, Thoratec Corporation initiated a voluntary worldwide Medical Device Correction in order to update its labeling and training materials for the HeartMate II(®) LVAS Pocket System Controller (the "Pocket Controller"). The following information is provided as a reinforcement of the initial release. Failure to completely connect the driveline during the process of exchanging Pocket System Controllers has resulted in serious...

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...


Word of the Day
penuche
  • A fudgelike confection of brown sugar, cream or milk, and chopped nuts.
'Penuche' is a variant of 'panocha,' a coarse grade of sugar made in Mexico. 'Panocha' probably comes from the Spanish 'panoja, panocha,' ear of grain.
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