Solara Active Pharma Ipo

Solara active pharma ipo

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:

Recall Reason Description

NDMA (Nitrosodimethylamine) impurity

Company Name:
Mylan N.V.

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Brand Name:
Product Description:

Product Description

Nizatidine Capsules 150mg and 300mg


Company Announcement

Mylan N.V.(NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall, to the consumer level, of three lots of Nizatidine Capsules, USP (including the 150mg and 300mg strengths).

Solara active pharma ipo

While Mylan has not received any reports of adverse events related to these batches to date, this product is being voluntarily recalled due to detected trace amounts of an impurity N-nitrosodimethylamine (NDMA) contained in the API Nizatidine, USP, manufactured by Solara Active Pharma Sciences Limited.

NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables.

NDMA has been classified as a probable human carcinogen (a substance that could cause cancer) according to the International Agency for Research on Cancer (IARC).

The finished products are manufactured by Mylan Pharmaceuticals Inc.

These batches were distributed nationwide to wholesalers, mail order pharmacies, retail pharmacies, and a distributor between June 2017 and August 2018.

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The recalled batches are as follows:

NDCProduct DescriptionStrengthSizeLot NumberExpiry
0378-5150-91Nizatidine Capsules, USP150mgBottles of 603086746May 2020
0378-5300-93Nizatidine Capsules, USP300mgBottles of 303082876Jan 2020
0378-5300-93

 

Nizatidine Capsules, USP

 

300mg

 

Bottles of 30

 

3082877

 

Jan 2020

 

Nizatidine is indicated for the short-term treatment (up to 8 weeks) of active duodenal ulcers and active benign gastric ulcers, as maintenance therapy for duodenal ulcer patients for up to one year, and for up to 12 weeks for the treatment of endoscopically diagnosed esophagitis and associated heartburn due to gastroesophageal reflux disease (GERD).

Mylan is notifying its distributors and customers by letter and is arranging for return of all recalled products.

Wholesalers, retailers and consumers that are in possession of recalled product should contact Stericycle at 888-628-0727 for the return of the recalled product.

Normal business hours are Monday through Friday 8 a.m.

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to 5 p.m. EST.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products.

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 Online
  • Regular Mail or Fax: Download form 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.

Solara active pharma ipo

Food and Drug Administration.

About Mylan

Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership.

Solara active pharma ipo

We offer a growing portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which approximately 40% of people being treated for HIV/AIDS globally depend. We market our products in more than 165 countries and territories. We are one of the world's largest producers of active pharmaceutical ingredients. Every member of our approximately 35,000strong workforce is dedicated to creating better health for a better world, one person at a time.

Solara active pharma ipo

Learn more at Mylan.com. We routinely post information that may be important to investors on our website at investor.mylan.com.

 


Company Contact Information

Consumers:
Stericycle
888-628-0727
Media:
Christine Waller
724-514-1968

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