October 04, 2018
Hetero Labs Limited is recalling 30-count bottles montelukast sodium tablets, 10 mg (NDC 31722-726-30), according to the October 3, 2018, US Food and Drug Administration (FDA) Enforcement Report. The recall was issued after a pharmacist reported blue specks on the tablets.
The recall affects 98,016 bottles manufactured for Camber Pharmaceuticals Inc. from lot MON17355 (Exp. 12/19). The bottles were distributed throughout the United States.
Hetero Labs Limited voluntarily initiated the recall August 20, 2018. On September 26, 2018, the FDA designated the recall Class II. The classification suggests use of the product could cause temporary or medically reversible adverse health consequences. Although the likelihood is remote, a possibility of serious harm also exists.
Montelukast sodium tablets are available with a prescription for management of asthma and seasonal allergy symptoms.
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