Aurobindo Pharma USA, Inc. Issues Voluntary Nationwide Recall of Mirtazapine Tablets Lot Number 03119002A3 Due to Label Error on Declared Strength

*When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company’s announcement as a public service. FDA does not endorse either the product or the company.

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https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/aurobindo-pharma-usa-inc-issues-voluntary-nationwide-recall-mirtazapine-tablets-lot-number?utm_campaign=Aurobindo%20Pharma%20USA%2C%20Inc.%20Issues%20Voluntary%20Nationwide%20Recall%20of%20Mirtazapine%20Tablets&utm_medium=email&utm_source=Eloqua

Summary
Company Announcement Date:
December 30, 2019
FDA Publish Date:
December 31, 2019
Product Type:
Drugs
Reason for Announcement:
Due to a label error on declared strength-bottles labeled as Mirtazapine 7.5 mg
Company Name:
Aurobindo Pharma USA, Inc.
Brand Name:
Aurobindo Pharma USA, Inc.
Product Description:
Mirtazapine Tablets 7.5 mg
Company Announcement
Aurobindo Pharma USA, Inc. is voluntarily recalling lot number 03119002A3 of Mirtazapine Tablets to the consumer level. The product is being recalled due to a label error on declared strength; bottles labeled as Mirtazapine 7.5 mg may contain 15 mg tablets.

Taking a higher dose than expected, may increase risk of sedation, agitation, increased reflexes, tremor, sweating, dilated pupils, gastrointestinal distress, nausea, constipation and more. Unexpected levels of sedation in particular can contribute to falls in the elderly or motor vehicle accidents in adults.

Mirtazapine tablets are indicated for the treatment of major depressive disorder and are packaged in 500 count bottles. The affected lot number for both Mirtazapine Tablets 7.5 mg and Mirtazapine Tablets 15 mg are 03119002A3 Exp 03/2022. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.

Aurobindo Pharma USA, Inc. is notifying its distributors by letter and is arranging for return of all of the recalled product. Distributors/retailers that have product which is being recalled should return the bottle(s) to place of purchase.

Consumers with medical questions regarding this recall or to report an adverse event can contact Aurobindo Pharma USA, Inc. at:

1-866-850-2876 Option 2
pvg@aurobindousa.com
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Any general questions regarding the return of this product please contact Qualanex at 1-888-504-2014 or email mecall@qualanex.com(live calls received 7:00 am to 4:00 pm M-F CST).

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report OnlineExternal Link Disclaimer
Regular Mail or Fax: Download formExternal Link Disclaimer or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Company Contact Information
Consumers:
Aurobindo Pharma USA
1-866-850-2876 Option 2
pvg@aurobindousa.com

(PORTLAND, Ore.) JUST IN: A man in a ‘white utility van ‘ tried to abduct a young 13yr-old-g irl walking along Harold Street near the I-205 underpass at 18:00pm on Sat.07: Dec: KATUNews ..Description o f the man is below …Can you help find him? #AceNewsDesk reports — Ace News Services

#AceNewsReport – Dec.09: A 13-year-old girl told police someone in a van tried to abduct her in Southeast Portland: The girl said she was walking along Harold Street near the I-205 underpass at about 6 p.m. Saturday (Dec. 7) when someone in a white utility van stopped next to her. She told investigators the driver […]

via (PORTLAND, Ore.) JUST IN: A man in a ‘white utility van ‘ tried to abduct a young 13yr-old-g irl walking along Harold Street near the I-205 underpass at 18:00pm on Sat.07: Dec: KATUNews ..Description o f the man is below …Can you help find him? #AceNewsDesk reports — Ace News Services

Hillary Takes Veiled Shot at Donald, Melania Trump During Elijah Cummings’ Funeral

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(Getty Images)

Hillary Takes Veiled Shot at Donald, Melania Trump During Elijah Cummings’ Funeral
https://www.breitbart.com/clips/2019/10/25/hillary-takes-veiled-shot-at-donald-melania-trump-during-elijah-cummings-funeral/
By: Pam Key
25 Oct 2019

On Friday during Rep. Elijah Cummings’ (D-MD) funeral, former Democratic presidential nominee Hillary Clinton used a Biblical analogy to take a veiled shot at President Donald Trump and first lady Melania Trump.

Clinton was comparing Cummings to his namesake, the Biblical prophet Elijah, who stood up against wicked King Ahab and Queen Jezebel.

Clinton said, “Like the prophet, our Elijah could call down fire from heaven — but he also prayed and worked for healing.”

She added, “Like that Old Testament prophet, he stood against corrupt leadership of King Ahab and Queen Jezebel.”

The crowd roared in acknowledgment.

Follow Pam Key on Twitter @pamkeyNEN

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(Cop Acquitted for Rape, Despite 5 Videos Showing Him Having Sex With a Child)

Despite overwhelming video and photo evidence against him and telling his victim not to testify, an NYPD detective was acquitted this month for child rape video

Cop Acquitted for Rape, Despite 5 Videos Showing Him Having Sex With a Child
Matt Agorist October 7, 2019

Cop Acquitted for Rape, Despite 5 Videos Showing Him Having Sex With a Child

New York, NY — Flexing his mighty blue privilege granted to him by his badge, a former NYPD cop was acquitted on felony child rape and sex abuse charges this month — despite filming the interactions with the 15-year-old victim himself. Instead of going to jail for years, like he should have, this cop will likely escape any actual accountability.

The ex-NYPD Police Officer Raul Olmeda was accused of recording his sexual encounters with the 15-year-old girl on at least five occasions. He was confronted with these videos by investigators and the teen admitted to the acts. These facts were indisputable, yet Olmeda was acquitted.

Instead of facing the time in prison for the felony rape charges, Olmeda was convicted of two petty misdemeanors of official misconduct and witness tampering. The witness tampering stems from the fact that Olmeda told the girl not to testify against him in court. The official misconduct charge was brought on after this cop was caught accessing NYPD computers to see what evidence internal affairs had against him.

Incredibly, he was only found guilty of the very charges which allowed him to silence his victim and give him an upper hand during the trial. It is utter insanity. The two misdemeanors barely carry up to a year in jail.

Even more insane is the fact that his attorney had the audacity to refer to Olmeda as a “victim.” You really cannot make this up.

“From the start, Mr. Olmeda was willing to take responsibility for his actions, but he was not willing to plead guilty to charges where he was the victim of a shakedown,” said Peter Brill, Olmeda’s lawyer. “We thank the jury for being able to tell the difference.”

The case against Olmeda began in 2017 when his victim, a 15-year-old girl, was arrested for prostitution. Because children cannot consent to sex with an adult, the idea of charging her with prostitution is wrong from the start. However, during her arrest, the victim told investigators that Olmeda had purchased her for sex on multiple occasions.

When police executed a search warrant on the officer’s home and computer, they found the videos and images on his computer and phone. When he was confronted with the videos, he refused to acknowledge that he knew the child. He also refused to identify his bedroom and living room furniture which were seen in the photos.

Astonishingly enough, the jury bought this denial. But it gets worse.

Despite the existence of the photos and videos found on his devices of a child having sex—a fact no one disputes—Olmeda was not found guilty of child pornography.

Also, despite claiming to investigators that he did not know the 15-year-old child, police found another video in which he was telling the girl to “lay low” as Internal Affairs investigated him.

“Technically you are a minor,” Olmeda told the teen, according to court records. So much for not knowing her.

Even more disturbing is the fact that after the initial raid found all the videos, Olmeda was not fired for seven months. This time allowed him to keep tabs on the Internal Affairs investigation of him. Prosecutors claim that Olmeda was even able to have sex with the teenager two more times after the raid.

Exactly how a jury would acquit a man, especially given the video and photo evidence documenting his crimes, is a tragic mystery. Now, however, the citizens of New York can rest assured that he will likely strike again as he faces less than a year behind bars.

This potential tendency to strike again was also evidenced by the other files investigators reportedly found on his computer named “the list,” in which he made a creepy PowerPoint presentation of other women with whom he has allegedly paid to have sex—all while his fiance battled cancer….a real stand up guy indeed.

When a police officer can be caught on video having sex with a child five times and escape the charges for it, we have a serious problem in this country. Olmeda’s acquittal shows us just how blinded by the badge some people can become. Given how often police officers are accused of horrifying sexual crimes, many of which are against children, this blindness should have been lifted long ago. However, judging from the lack of time behind bars they are consistently given, we can assume that it is still alive and well.