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FDAJanuary 7, 2017drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

hetero

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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