U.S. Markets close in 6 hrs 22 mins

Featured Company News - Pfizer Receives Warning Letter from FDA Highlighting Manufacturing Defects in the EpiPen Administered for Anaphylaxis

Research Desk Line-up: Alliqua BioMedical Post Earnings Coverage

LONDON, UK / ACCESSWIRE / September 11, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Pfizer Inc. (NYSE: PFE), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=PFE. The Company announced on September 08, 2017, that it received a warning letter from the US Food and Drug Administration (FDA) concerning the FDA's inspection of a Missouri manufacturing facility between February and March 2017. According to the warning letter, significant violations of current good manufacturing practices were observed. The manufacturing unit failed to thoroughly investigate multiple serious components and product failures, including the failures associated with patient deaths and severe illness. For immediate access to our complimentary reports, including today's coverage, register for free now at:


Discover more of our free reports coverage from other companies within the Drug Manufacturers - Major industry. Pro-TD has currently selected Alliqua BioMedical, Inc. (NASDAQ: ALQA) for due-diligence and potential coverage as the Company announced on August 10, 2017 its financial results for Q2 2017 which ended on June 30, 2017. Tune in to our site to register for a free membership, and be among the early birds that get our report on Alliqua BioMedical when we publish it.

At Pro-TD, we make it our mission to bring you news that matter about the stock you follow. Today, our research desk covers a blog story on PFE; also brushing on ALQA. Go directly to your stock of interest and access today's free coverage at:



EpiPen, or the Epinephrine injection, is administered when a person has an allergic emergency, also known as anaphylaxis. Anaphylaxis occurs when the body perceives a trigger as a threat and starts forming antibodies to defend itself. These antibodies cause the release of certain molecules that indicate the immediate symptoms of the disease. Epinephrine, popularly known as "adrenaline," constricts the blood vessels to increase blood pressure, relaxes smooth muscles in the lungs to facilitate breathing, stimulates the heart, and works further to reduce the swelling that may occur around the face and lips.

The FDA Letter

The letter stated that, in February 2016, Meridian found that one unit of an EpiPen component that ensures the product delivers its dose of epinephrine did not work. The Company rejected the particular lot and another one, but later, continued to manufacture its products while the investigation continued through October 2016, according to the FDA letter. During the period, Meridian received hundreds of complaints where EpiPen failed to operate in emergencies, and where, in some situations, the error was fatal.

The letter also outlined the Company's failure to analyze sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems. Pfizer, in its defense, stated that between 2015 and now, it has shipped over 30 million EpiPen Auto-Injectors globally. According to the Company, it is not unusual to receive product complaints, especially when the EpiPen is administered by non-medically trained individuals. It further stated in an emailed statement that it currently has no information to indicate that there was any causal connection between these product complaints and any patient deaths.

The Mass Recall

The letter further stated that Pfizer did not thoroughly investigate the complaints, nor did it remove potentially defective products from the marketplace, even after it had identified a defect in one of the critical components used to manufacture the products and even after it had confirmed the same or similar component defect as the root cause of multiple complaints.

According to a May 2016 investigation into a customer complaint, a similar manufacturing defect was found from the February inspection, but the Company concluded that the defect was infrequent, and did not link the two issues to take market action. Of 172 complaint samples between 2014 and 2017 for products that did not activate correctly, Meridian disassembled and examined very few of them, according to the FDA.

Last Close Stock Review

On Friday, September 8, 2017, the stock closed the trading session at $34.10, marginally rising 0.32% from its previous closing price of $33.99. A total volume of 15.04 million shares have exchanged hands. Pfizer's stock price advanced 1.94% in the last one month and 4.06% in the past three months. Furthermore, since the start of the year, shares of the Company have gained 4.99%. The stock is trading at a PE ratio of 24.84 and has a dividend yield of 3.75%. The stock currently has a market cap of $203.17 billion.

Pro-Trader Daily:

Pro-Trader Daily (Pro-TD) produces regular sponsored and non-sponsored reports, articles, stock market blogs, and popular investment newsletters covering equities listed on NYSE and NASDAQ and Canadian stocks. PRO-TD has two distinct and independent departments. One department produces non-sponsored analyst certified content generally in the form of press releases, articles and reports covering equities listed on NYSE and NASDAQ and the other produces sponsored content (in most cases not reviewed by a registered analyst), which typically consists of compensated investment newsletters, articles, and reports covering listed stocks and micro-caps. Such sponsored content is outside the scope of procedures detailed below.

PRO-TD has not been compensated; directly or indirectly; for producing or publishing this document.


The non-sponsored content contained herein has been prepared by a writer (the "Author") and is fact checked and reviewed by a third party research service company (the "Reviewer") represented by a credentialed financial analyst [for further information on analyst credentials, please email contact@protraderdaily.com. Rohit Tuli, a CFA reg; charterholder (the "Sponsor"), provides necessary guidance in preparing the document templates. The Reviewer has reviewed and revised the content, as necessary, based on publicly available information which is believed to be reliable. Content is researched, written and reviewed on a reasonable-effort basis. The Reviewer has not performed any independent investigations or forensic audits to validate the information herein. The Reviewer has only independently reviewed the information provided by the Author according to the procedures outlined by PRO-TD. PRO-TD is not entitled to veto or interfere in the application of such procedures by the third-party research service company to the articles, documents or reports, as the case may be. Unless otherwise noted, any content outside of this document has no association with the Author or the Reviewer in any way.


PRO-TD, the Author, and the Reviewer are not responsible for any error which may be occasioned at the time of printing of this document or any error, mistake or shortcoming. No liability is accepted whatsoever for any direct, indirect or consequential loss arising from the use of this document. PRO-TD, the Author, and the Reviewer expressly disclaim any fiduciary responsibility or liability for any consequences, financial or otherwise arising from any reliance placed on the information in this document. Additionally, PRO-TD, the Author, and the Reviewer do not (1) guarantee the accuracy, timeliness, completeness or correct sequencing of the information, or (2) warrant any results from use of the information. The included information is subject to change without notice.


This document is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed, and is to be used for informational purposes only. Please read all associated disclosures and disclaimers in full before investing. Neither PRO-TD nor any party affiliated with us is a registered investment adviser or broker-dealer with any agency or in any jurisdiction whatsoever. To download our report(s), read our disclosures, or for more information, visit http://protraderdaily.com/disclaimer/.


For any questions, inquiries, or comments reach out to us directly. If you're a company we are covering and wish to no longer feature on our coverage list contact us via email and/or phone between 09:30 EDT to 16:00 EDT from Monday to Friday at:

Email: contact@protraderdaily.com
Phone number: (917) 341.4653
Office Address: Mainzer Landstrasse 50 Frankfurt am Main, Germany 60325

CFA reg; and Chartered Financial Analyst reg; are registered trademarks owned by CFA Institute.

SOURCE: Pro-Trader Daily