Drug Enforcement D-0002-2025

Defective Container: Firm received complaints of broken tube at the seal.

Status

Ongoing

Classification

Class III

Report Date

October 9, 2024

Termination Date

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Product Information

Product description
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.
Product quantity
11,568 tubes
Reason for recall
Defective Container: Firm received complaints of broken tube at the seal.
Recall initiation reason
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Initial firm notification
N/A
Distribution pattern
Nationwide in the US.

Location & Firm

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

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0002-2025
Event ID
95444
Recall initiation date
September 30, 2024
Center classification date
October 2, 2024
Code info
Lot #s: a) 19242028, Exp. 04/30/2026; b) 19242028, Exp. 04/30/2026; c) 19242028, Exp. 04/30/2026
More code info
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