Hetero USA Inc recalls Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway…

Recall date

January 7, 2017

Source

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

Recall number

D-0623-2017

FDA classification

Class III

Brand / firm

Hetero USA Inc

Sold / distributed

US Nationwide

Why it was recalled

Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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