August 2018 FDA Recall Montelukast Sodium by Hetero Labs Limited Unit V
D-1213-2018 - Discoloration
This Class II drug recall was voluntarily initiated by Hetero Labs Limited Unit V on August 20, 2018 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-1213-2018
Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
08-20-2018
10-03-2018
98,016 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
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 Labs Limited Unit V
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
11-05-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-726-30.
Batch or Lot Expiration Information
Lot# : MON17355, Exp 12/19
