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Clobetasol Propionate Foam (Emulsion Formulation), 0.05% a) 50 g pack (NDC 68462-625-27) and b) 1...

FDA Recall #D-0619-2020 — Class III — November 15, 2019

Recall #D-0619-2020 Date: November 15, 2019 Classification: Class III Status: Terminated

Product Description

Clobetasol Propionate Foam (Emulsion Formulation), 0.05% a) 50 g pack (NDC 68462-625-27) and b) 100 g pack (NDC 68462-625-94), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited Plot No. B-25, MIDC, Shendra Aurangabad, Maharashtra -431210, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430

Reason for Recall

Defective delivery system; product is not foaming or is coming out as liquid.

Recalling Firm

Glenmark Pharmaceuticals Inc., USA — Mahwah, NJ

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

a) 480 packs; b) 240 packs

Distribution

Nationwide

Code Information

Lot 14190067, exp Jul-2021

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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