Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

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Announcement

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg.

A consumer who inadvertently consumes Losartan may experience renal dysfunction, hyperkalemia, and hypotension. Hypotension (dizziness, fatigue) would be the most likely risk if Losartan was taken by an otherwise healthy patient (no concomitant conditions other than asthma or allergic rhinitis; no other concomitant medications). Losartan has a warning for fetal toxicity. There is risk of fetal morbidity and death if pregnant women unknowingly take Losartan instead of Montelukast. Camber Pharmaceuticals, Inc has not received any reports of adverse events related to this recall.

Montelukast Sodium Tablets is used to treat the symptoms of seasonal (occurs only at certain times of the year), and perennial (occurs all year round) allergic rhinitis (a condition associated with sneezing and stuffy, runny or itchy nose). Losartan is used alone or in combination with other medications to treat high blood pressure. Losartan is also used to decrease the risk of stroke in people who have high blood pressure and a heart condition called left ventricular hypertrophy (enlargement of the walls of the left side of the heart).

The recalled product is packaged in 30ct bottles labeled NDC is 31722-726-30. Montelukast Sodium tablets are beige, rounded square-shaped, film coated tablets debossed with "I" on one side and "114" on the other side. The impacted lot of Montelukast Sodium Tablets, USP 10mg was distributed Nationwide to Wholesalers, Distributors, and Retailers.

This recall is not related to the recent valsartan recalls that were due to an impurity, N-nitrosodimethylamine (NDMA).

Wholesalers, Distributors, and Retailers that have Montelukast Sodium Tablets, USP 10mg, lot# MON17384, which is being recalled should stop dispensing and quarantine any product in inventory.

Consumers with questions regarding this recall can contact Camber Pharmaceuticals' Med Line at 1-866-495-1995 Monday - Friday 9am - 5pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

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