August 2018 FDA Recall Montelukast Sodium by Hetero Labs Limited Unit V
D-0081-2019 - Labeling
This Class I drug recall was voluntarily initiated by Hetero Labs Limited Unit V on August 15, 2018 for the product Montelukast Sodium. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0081-2019
Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.
08-15-2018
10-03-2018
98016 bottles
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
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.
U.S.A. Nationwide
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, By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manfuactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, NDC 31722-726-30
Batch or Lot Expiration Information
Lot# : MON17384, Exp 12/19
