Hetero Labs Limited Unit V recalls Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherl…

Recall date

August 15, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0081-2019

FDA classification

Class I

Brand / firm

Hetero Labs Limited Unit V

Sold / distributed

U.S.A. Nationwide

Why it was recalled

Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manfuactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, NDC 31722-726-30