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FDA Announces Voluntary Recall of Montelukast Tablets

Mixup with Losartan Discovered in Bottles

The FDA is warning consumers and health care professionals about a voluntary recall of one lot of Montelukast Sodium Tablets – lot number MON17384, expiration 12/31/2019 – by Camber Pharmaceuticals, Inc., in Piscataway, N.J. Sealed bottles labeled as montelukast sodium tablets, 10 milligrams (mg), 30-count bottle from Camber were found to instead contain 90 tablets of Losartan Potassium Tablets, 50 mg.

This tablet mix-up may pose a safety risk, as taking losartan tablets when not prescribed has the potential to cause renal dysfunction, elevated potassium levels, and low blood pressure. This risk is especially high for pregnant women. The FDA is urging consumers who have this recalled product to contact their health care provider or pharmacist immediately.

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.

The recalled lots of montelukast sodium tablets, USP 10 mg have the following information:

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

To date, Camber has not received adverse event reports associated with this recall.

Source: FDA.gov, August 31, 2018

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