September 2024 FDA Recall Drug by Glenmark Pharmaceuticals Inc., Usa
D-0002-2025 - Defective Container

This Class III drug recall was voluntarily initiated by Glenmark Pharmaceuticals Inc., Usa on September 30, 2024 for the product Drug. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0002-2025

Reason for Recall
Defective Container: Firm received complaints of broken tube at the seal.
Initiated
09-30-2024
Reported
10-09-2024
Quantity
11,568 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95444
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Ongoing
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the US.
Product Description About Product Description
Full technical description of the product.
Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes, Rx Only, a) 30 gm Tube, NDC 68462-0455-35; b) 45 gm Tube, NDC 68462-0455-47; c) 100 gm Tube, NDC 68462-0455-94, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.

Batch or Lot Expiration Information

Lot# s: a) 19242028, Exp. 04/30/2026; b) 19242028, Exp. 04/30/2026; c) 19242028, Exp. 04/30/2026