U.S. Markets open in 5 hrs 44 mins

Mylan Recalls Valsartan Lots, Gets FDA Warning for Facility

Mylan N.V. MYL announced that it would voluntary recall select lots of blood pressure medicine Valsartan in the United States. The company recalled these due to traces of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Valsartan, manufactured by Mylan Laboratories Limited. 

Mylan stated that it would recall at least 15 lots of medicines containing valsartan distributed in the United States between March 2017 and November 2018 and manufactured by units Mylan Pharmaceuticals and Mylan Laboratories.

The company also commented on a Warning Letter it received from the FDA on Nov 9, which raised concerns related to its manufacturing facility in Morgantown, WV. The company has implemented a comprehensive restructuring and remediation plan at this facility. Considering the company's ongoing restructuring at this facility, Mylan said there is a temporary disruption in supply of certain products, and it has discontinued some products and transferred others to different facilities. The company stated that these activities are already reflected in its 2018 outlook, and the issues raised in the Warning Letter are being addressed within the context of this plan. 

Shares of the company fell about 2% following the news. However, the shares of the company have declined 19.8% year to date compared with the industry’s decline of 9.3%.

 

Mylan N.V. Price

Mylan N.V. Price | Mylan N.V. Quote

Zacks Rank & Stocks to Consider

Mylan is a Zacks Rank #3 (Hold) stock.

Some better-ranked stocks worth considering are Bristol-Myers Squibb Company BMY, Johnson and Johnson JNJ and Merck & Co. MRK. While Bristol-Myers sports a Zacks Rank #1 (Strong Buy), J&J and Merck carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Bristol-Myers’ earnings per share estimates have increased from $3.62 to $3.84 for 2018 and from $3.82 to $4.08 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters with average of 11.99%.

J&J’s earnings per share estimates have increased from $8.14 to $8.16 for 2018 and from $8.61 to $8.66 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters with average of 1.65%. Shares of the company have increased 36% year to date.

Merck’s earnings per share estimates have increased from $4.27 to $4.34 for 2018 and from $4.63 to $4.71 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters with average of 3.96%. Shares of the company have increased 36% year to date.

Looking for Stocks with Skyrocketing Upside?

Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.

Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look.