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Medication Safety Alerts

Montelukast sodium 10 mg Tablets Voluntary Recall

August 31, 2018

On August 31, 2018, the United States Food and Drug Administration (FDA) issued a notice regarding voluntary recall of montelukast sodium 10 mg tablets manufactured by Camber Pharmaceuticals, Inc. This recall was issued because sealed bottles labeled as montelukast sodium 10 mg tablets contained losartan potassium 50 mg tablets. Taking losartan tablets when not prescribed could cause serious side effects such as kidney problems, elevated potassium levels and low blood pressure. In pregnant women, taking losartan could harm a fetus.

This may represent a potential health hazard or safety risk to plan members who may be using product affected by this recall.

Members should call their doctor or pharmacist to determine if their medicine has been recalled. Members should also look at the drug name and company name on the label of their prescription bottle. If the information is not on the bottle, members should contact the pharmacy that dispensed the medicine.

If you received your medicine in the Manufacturer’s bottle

This recall affects lot number MON17384 exp. 12/31/2019. To see if you received product from this affected lot, please check the lot number. The lot number is on the manufacturer’s label on the bottle. If your product is not from lot number MON17384 exp. 12/31/2019, it is not affected by this recall.

If you received your medicine in the Manufacturer’s or Pharmacy’s bottle

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 other side. If your product does not match the montelukast sodium tablet description, do not continue to use the product. If you are unsure, contact your doctor for confirmation.

If your product is affected by this recall, please contact the pharmacy that filled your prescription for further instructions.

You should not continue to use product that is affected by this recall. You should not continue to use product that is affected by this recall. Please call your doctor right away for advice if you may be using affected product. Your doctor is familiar with your

medical history and can suggest the best treatment option for you. If you need a prescription for a different medicine, please call your doctor.

CVS Caremark Response: If you are currently taking montelukast sodium 10 mg tablets, please call a Customer Care representative toll-free at 1-866-823-5184. We will give you more information and help with arrangements for the return and replacement of any affected product.

If you are currently taking montelukast sodium 10 mg tablets and have questions regarding this recall, please call Camber’s Medical Line toll-free at 1‑866‑495-1995 or visit www.camberpharma.com. You may also call the FDA consumer inquiry line toll-free at 1‑888‑INFO-FDA (1‑888-463-6332) or visit www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm619174.htm.

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