D-0621-2024 Class II Ongoing
FDA drug recall D-0621-2024 was initiated by Glenmark Pharmaceuticals Inc., USA on Jul 22, 2024 and is designated Class II. Reason for recall: CGMP Deviations The recall status is ongoing. Affected quantity: 14,004 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 7, 2024
- Initiation Date
- Jul 22, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,004 cartons
Product Description
Glenmark, Azelaic Acid Gel, 15 %, 50 grams, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa, 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-626-52.
Reason for Recall
CGMP Deviations
Distribution Pattern
U.S. Nationwide
Code Information
Lot# 19241453; Exp MARCH 2026
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0621-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026