January 2017 FDA Recall Montelukast Sodium by Hetero Usa Inc
D-0623-2017 - Discoloration
This Class III drug recall was voluntarily initiated by Hetero Usa Inc on January 7, 2017 for the product Montelukast Sodium. The FDA reported the reason for recall as discoloration. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0623-2017
Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.
01-07-2017
04-05-2017
65,664 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hetero USA Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
US Nationwide
08-08-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# MON16001B, Exp 01/18
