Drug 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

D-0623-2017

January 07, 2017

Class III

Product summary

Firm: Hetero USA Inc
Event: Event 76412
Status: Terminated
Classification: Class III
Quantity: 65,664 bottles
Official record key: drug-enforcement:D-0623-2017

Official wording

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

Code information: Lot # MON16001B, Exp 01/18

Distribution pattern: US Nationwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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