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Home Prescription medicine Glenmark Pharmaceuticals Inc., USA — Ciclopirox…

Food & drug recall · FDASeptember 30, 2024Labelling issue

Glenmark Pharmaceuticals Inc., USA — 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

Do not stop taking this without speaking to your pharmacist or doctor.

What’s wrong

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

The Recall Registry rates this labelling issueFDA Class III: unlikely to cause harm.

What to do

Check the lot numbers below against what you have. Do not stop taking a prescription medicine because of a recall without speaking to your pharmacist or doctor first — for many medicines stopping is more harmful than continuing, and they can tell you whether yours is affected and what to do about it.

Who to contact: Recalling firm: Glenmark Pharmaceuticals Inc., USA

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.

Details

Units affected
11,568 tubes
Recall date
September 30, 2024
Brand
Glenmark Pharmaceuticals Inc., USA
Model, lot or SKU numbers
Lot #s: a) 19242028, Exp. 04/30/2026b) 19242028, Exp. 04/30/2026c) 19242028, Exp. 04/30/2026
Where it was distributed

Nationwide in the US

The official notice

This recall was issued by the U.S. Food and Drug Administration. The Recall Registry summarises it — always confirm the details at the source.

Their exact wording: Glenmark Pharmaceuticals Inc., USA — 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: Glen

Read it on FDA

Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.

Filed under: Prescription medicine

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