Class III
Terminated
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
- Company
- Hetero Usa Inc
- Recall Initiated
- January 7, 2017
- Posted
- April 5, 2017
- Recall Number
- D-0623-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 65,664 bottles
- Firm Location
- Piscataway, NJ, United States
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
Lot / Code Info
Lot # MON16001B, Exp 01/18
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