FDAAugust 20, 2018drug

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

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

The hazard

Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.

What to do

FDA enforcement status: Terminated

Brands named

hetero labs limited unit vheterohetero labs

Recall history

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

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