Sharing our perspective

Sharing perspectives leads to greater understanding and fuels innovation. The ​Optum Insights ​blog is where we share our perspective and challenge preconceptions to clear a new path forward.


Recall of one lot of montelukast 10 mg tablets

by | Sep 05, 2018

The U.S. Food and Drug Administration (FDA) announced that Camber Pharmaceuticals, Inc., voluntarily recalled one lot of montelukast sodium 10 mg tablets. This recall was issued following a discovery that sealed 30-count bottles, labeled as montelukast sodium 10 mg, from Camber were found to instead contain ninety tablets of losartan potassium 50 mg.

Montelukast sodium (generic for Singulair®) is generally prescribed for the treatment of asthma and allergic rhinitis. Losartan potassium (generic for Cozaar®) is generally prescribed alone or in combination with other medications to treat high blood pressure.

This mislabeling may pose a safety risk as taking losartan tablets when not prescribed has the potential to cause low blood pressure, kidney dysfunction, and high potassium levels. This risk is especially high for pregnant women taking montelukast because losartan could harm or kill the fetus.

Recalled lots of montelukast sodium tablets 10 mg have the following information:

  • Label: Montelukast Sodium Tablets 10 mg, 30-count bottle
  • Lot number: MON17384
  • Expiration date: 12/31/2019
  • NDC: 31722-726-30

According to the notice, “montelukast sodium tablets are beige, rounded square-shaped, film coated tablets that are imprinted with “I” on one side and “114” on the reverse. Losartan tablets are white and oval-shaped with the letter “I” imprinted on one side and the number “5” imprinted on the reverse.”

To date, Camber has not received adverse event reports associated with this recall. Any claimants using montelukast should check the lot number and expiration date on their bottle. If the medication they are using is part of this recall, they should immediately contact their pharmacist, doctor or healthcare provider.

For more information on this recall, please click here.

If you have any questions, please contact your account manager, clinical liaison or our Clinical Services team at 1-877-275-7674 ext. 8612.

Sources:

  1. U.S. Food and Drug Administration News & Events. Newsroom: Press Announcements. FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles. August 31, 2018. Available at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm619174.htm.
    [Accessed August 31, 2018]
  2.