Drug Enforcement D-0621-2024

CGMP Deviations

Status

Ongoing

Classification

Class II

Report Date

August 7, 2024

Termination Date

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Product Information

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.
Product quantity
14,004 cartons
Reason for recall
CGMP Deviations
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
U.S. Nationwide

Location & Firm

Recalling firm
Glenmark Pharmaceuticals Inc., USA
Address
750 Corporate Dr, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0621-2024
Event ID
95022
Recall initiation date
July 22, 2024
Center classification date
July 29, 2024
Code info
Lot# 19241453; Exp MARCH 2026
More code info
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