FDA recall D-0623-2017

Product

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

Reason for recall

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

Distribution

US Nationwide

Key facts

Status

Terminated

Initiation date

2017-01-07

Report date

2017-04-05

Termination date

2017-08-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Piscataway, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0623-2017