January 2020 FDA Recall Montelukast Sodium by Macleods Pharma Usa Inc
D-0823-2020 - Failed Dissolution Specifications
This Class III drug recall was voluntarily initiated by Macleods Pharma Usa Inc on January 20, 2020 for the product Montelukast Sodium. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0823-2020
Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
01-20-2020
02-05-2020
10680 units
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.
Macleods Pharma 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
04-26-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc. Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himachal Pradesh, India NDC 33342-111-10
Batch or Lot Expiration Information
Lot# : BMD8901B, Exp. Date 02/2021
