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Endo Recalls 2 Lots of Robaxin Tablets Due to Labeling Error

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Endo International plc (ENDP - Free Report) announced the recall of two lots of its muscle relaxant drug, Robaxin 750mg Tablets 100 Count Bottle pack due to incorrect labeling of daily dosing information. The label on the products states a daily dose of "two to four tablets four times daily" instead of the correct dosage of "two tablets three times daily."

The drug is available as an adjunct therapy to rest, physical therapy and other measures to relieve patients of discomfort associated with acute, painful musculoskeletal conditions.

The company stated that incorrect dosage information can cause significant drowsiness or dizziness or an overdose leading to seizures, coma, or death. However, the company has not received any adverse report to date.

The two lots, which were recalled, include 216702P1, Expiration Date: September 2020 and 220409P1, Expiration Date: January 2021.

Endo’s stock has gained 117.2% in the year so far compared with the industry’s 4.3% rise.

 

The company is focused on redefining its business as its generic division is facing challenges and persistent decline in sales, which is expected to continue for the rest of 2018. Moreover, the withdrawal of Opana ER on FDA’s request is also hurting sales of the U.S. Branded Pharmaceuticals unit

However, the company’s flagship product, Xiaflex, has shown strong growth and Endo remains committed to expand the label of the drug. The company’s sterile injectables business is also performing well on the back of strong demand for Adrenalin. The segment holds potential to become Endo’s core business.

The company raised its annual guidance for earnings as well as revenues on its second-quarter earnings call. However, the company will take time to counter its generic division woes and a turnaround should take time.

Zacks Rank & Key Picks

Endo currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks from the pharma space are BioSpecifics Technologies Corp (BSTC - Free Report) , Champions Oncology, Inc. (CSBR - Free Report) and Akebia Therapeutics, Inc. (AKBA - Free Report) . While BioSpecifics and Champions Oncology sport a Zacks Rank #1 (Strong Buy), Akebia carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

BioSpecifics’ earnings per share estimates have increased from $2.09 to $2.28 for 2018 and from $2.13 to $2.38 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 11.37%. The stock has rallied 35% so far this year.

Champions Oncology’s earnings per share estimates have moved up from 5 cents to 17 cents for 2018 and from 20 cents to 25 cents for 2019 over the past 30 days. The company delivered an average beat of 200%. The stock has rallied 350.3% so far this year.

Akebia’s loss per share estimates have narrowed from $2.77 to $2.70 for 2018 and from $3.02 to $2.85 for 2019 over the past 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 66.56%.

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