D-0349-2019 Class III Terminated

Recalled by Glenmark Pharmaceuticals Inc., USA — Mahwah, NJ

FDA drug recall D-0349-2019 was initiated by Glenmark Pharmaceuticals Inc., USA on Nov 27, 2018 and is designated Class III. Reason for recall: Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blister pack. The recall status is terminated (terminated Sep 12, 2019). Affected quantity: 5,016 blister packs.

Recall Details

Product Type
Drugs
Report Date
Dec 26, 2018
Initiation Date
Nov 27, 2018
Termination Date
Sep 12, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,016 blister packs

Product Description

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

Reason for Recall

Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blister pack.

Distribution Pattern

Nationwide

Code Information

Lot: 17180918, EXP June 2020

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-0349-2019
openFDA file date
Oct 21, 2026
Loaded by RegDataLab
Oct 23, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.