FDA-Drug2017-04-05Class III
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
Hetero USA Inc
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.
Sold states
US Nationwide
Affected count
65,664 bottles
Manufactured in
1035 Centennial Ave, Piscataway, NJ, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0623-2017Don't want to check this manually?
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