http://www.fda.gov/oc/po/firmrecalls/neilgen04_09.html
Recall — Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Neilgen Pharma Inc. and Advent Pharmaceutical Recall All Prescription Cough and Cold Drug Products Sold on or after March 5, 2008
Contact:
Bharat Patel, President
(609) 448-5500
FOR IMMEDIATE RELEASE — April 20, 2009 — Neilgen Pharma Inc. of Westminster, MD and Advent Pharmaceutical of East Windsor, NJ are recalling all prescription cough and cold drug products sold on or after March 5, 2008. Neilgen Pharma and Advent Pharmaceutical are contract manufacturers for these products and are recalling the listed products below due to the unapproved drug product category.
Consumers taking these recall products which is being recalled shouldstop using and return product to place of purchase and contact their physician or healthcare provider to obtain a replacement medication or prescription.
Safety and effectiveness have not been established by FDA. However, patient exposure to affected products is not likely to cause adverse health consequences. Both Neilgen Pharma and Advent Pharma have stopped the production of these products and no injuries have been reported to date.
This precautionary action is focused on removing products to the retail level only. FDA has been apprised of this action. All of the products under recall were distributed to wholesalers located in Alabama and North Carolina.
The drug products can be identified by provided name, description and lot numbers.
Inquiries related to this recall should be addressed to Advent Pharma Customer Services at 1-888-634-5522. Representative is available Monday through Friday, 8 a.m. to 5 p.m. EST.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s Adverse Event Reporting program either online, by regular mail or by fax.
This recall includes all lots manufactured/distributed on or after March 5, 2008 within expiration date of the product listed below.
Advent Pharma Recalled Products
Name
Product Description
Lot Number
RY-Tann
Caplets
Phenylephrine Tannate 25 mg/ Chlorpheniramine Tannate 9 mg Caplets
806009, 806010,
806011
D-Tann CT
Caplets
Diphenhydramine Tannate/Phenylephrine Tannate/ Carbetapentane Tannate
25/10/30 mg Caplets
806003, 806004
Neilgen Pharma Recalled Products
Name
Product Description
Lot Number
D-Tann Suspension
Diphenhydramine Tannate/Phenylephrine Tannate 25/7.5 mg Suspension
L08C192, L08D171, L08E121, L08E131,
D-Tann CT
Suspension
Diphenhydramine Tannate/Phenylephrine Tannate/ Carbetapentane Tannate
25/10/30 mg Suspension
L08C201, L08E071,
L08E091
Ben-Tann
Suspension
Diphenhydramine Tannate 25 mg Suspension
L08D032, L08E061
D-Tann AT
Suspension
Diphenhydramine Tannate/ Carbetapentane Tannate 25/30 mg Suspension
L08E271, L08E281
D-Tann CD
Suspension
Diphenhydramine Tannate/ Phenylephrine Tannate/
Carbetapentane Tannate 25/15/30 mg Suspension
L08F051
D-Tann DM
Suspension
Diphenhydramine Tannate/ Phenylephrine Tannate/
Dextromethorphan Tannate 25/7.5/75 mg Suspension
L08F121, L08F131
B-Vex
Suspension
Brompheniramine Tannate 12 mg Suspension
L08D031, L08E021,
L08E051
B-Vex D
Suspension
Brompheniramine Tannate/ Phenylephrine Tannate 12/20 mg Suspension
L08D031, L08D181
BROM TANN
8 mg/DM TANN
60 mg/PSE TANN
90 mg Suspension
Brompheniramine Tannate/ Dextromethorphan Tannate/
Pseudoephedrine Tannate 8/60/90 mg Suspension
L08C181, L08D041
DM Tann
30 mg/ PE Tann/25
mg Brom Tann
10 mg Suspension
Dextromethorphan Tannate/ Phenylephrine Tannate/
Brompheniramine Tannate 30/25/10 mg Suspension
L08D091, L08D223
L08E161, L08F111
PE Tann 20 mg/
CP Tann 4 mg
Suspension
Phenylephrine Tannate/ Chlorpheniramine Tannate 20/4 mg Suspension
L08D222, L08E201
L08F102
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Yes, California, There Is an Individual Right to Keep and Bear Arms
Posted by Ilya Shapiro
Last June, the Supreme Court ruled in District of Columbia v. Heller that the Second Amendment protects an individuals right to keep and bear arms, at least in the home for self-defense. Heres our own Bob Levy, who masterminded the Heller litigation, talking about that decision:
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Yes, California, There Is an Individual Right to Keep and Bear Arms
Posted by Ilya Shapiro
Last June, the Supreme Court ruled in District of Columbia v. Heller that the Second Amendment protects an individuals right to keep and bear arms, at least in the home for self-defense. Heres our own Bob Levy, who masterminded the Heller litigation, talking about that decision:
While the Courts ruling was a watershed in constitutional interpretation, it technically applied only to D.C., striking down the Districts draconian gun ban but not having a direct effect in the rest of the country.
Well, today the Ninth Circuit (the federal appellate court covering most Western states) ruled that the Second Amendment restricts the power of state and local governments to interfere with individual right to have guns for personal use. That is, the Fourteenth Amendment incorporates the Second Amendment against the states, as the Supreme Court has found it to do for most of the Bill of Rights. I rarely get a chance to say this, but the Ninth Circuit gets it exactly right.
Heres the key part of Judge Diarmuid OScannlains opinion:
We therefore conclude that the right to keep and bear arms is deeply rooted in this Nations history and tradition. Colonial revolutionaries, the Founders, and a host of commentators and lawmakers living during the first one hundred years of the Republic all insisted on the fundamental nature of the right. It has long been regarded as the true palladium of liberty. Colonists relied on it to assert and to win their independence, and the victorious Union sought to prevent a recalcitrant South from abridging it less than a century later. The crucial role this deeply rooted right has played in our birth and history compels us to recognize that it is indeed fundamental, that it is necessary to the Anglo-American conception of ordered liberty that we have inherited. We are therefore persuaded that the Due Process Clause of the Fourteenth Amendment incorporates the Second Amendment and applies it against the states and local governments.
In short, residents of Alaska, Arizona, California, Hawaii, Idaho, Montana, Nevada, Oregon, and Washington now join D.C. residents in having their Second Amendment rights protected. And courts covering other parts of the country most immediately the Seventh Circuit, based in Chicago will have their chance to make the same interpretation in due course.
Just as interesting and potentially equally significant is the footnote Judge OScannlain drops at the end of the above text in response to arguments that the right to keep and bear arms, regardless of its provenance as a fundamental natural right, is now controversial:
But we do not measure the protection the Constitution affords a right by the values of our own times. If contemporary desuetude sufficed to read rights out of the Constitution, then there would be little benefit to a written statement of them. Some may disagree with the decision of the Founders to enshrine a given right in the Constitution. If so, then the people can amend the document. But such amendments are not for the courts to ordain.
Quite right.
Ilya Shapiro April 20, 2009 @ 5:21 pm