Drug recall D-0623-2017

Class III Terminated reported Apr 5, 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.

Lots and codes

Lot # MON16001B, Exp 01/18

Recall details

Recalling firm
Hetero USA Inc, Piscataway, NJ
Quantity
65,664 bottles
Distribution
US Nationwide
Type
Voluntary: Firm initiated
Recall initiated
January 7, 2017
Terminated
August 8, 2017

Related products