D-0623-2017 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 5, 2017
- Initiation Date
- January 7, 2017
- Termination Date
- August 8, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 65,664 bottles
Product Description
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 Pattern
US Nationwide
Code Information
Lot # MON16001B, Exp 01/18