November 2018 FDA Recall Aprepitant by Glenmark Pharmaceuticals Inc., Usa
D-0349-2019 - Shortfill
This Class III drug recall was voluntarily initiated by Glenmark Pharmaceuticals Inc., Usa on November 27, 2018 for the product Aprepitant. The FDA reported the reason for recall as shortfill. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0349-2019
Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blister pack.
11-27-2018
12-26-2018
5,016 blister packs
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.
Glenmark Pharmaceuticals Inc., USA
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
09-12-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Aprepitant Capsules, USP 40 mg, 1 capsule Unit Blister Pack, Rx Only, Manufactured in India for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. UPC 368462583401. NDC 68462-583-40
Batch or Lot Expiration Information
Lot# Lot: 17180918, EXP June 2020
