Class III
Terminated
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
This recall has been terminated (originally issued December 18, 2019).
- Recall Initiated
- November 15, 2019
- Posted
- December 18, 2019
- Recall Number
- D-0619-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 480 packs; b) 240 packs
- Firm Location
- Mahwah, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Defective delivery system; product is not foaming or is coming out as liquid.
Distribution
Nationwide
Lot / Code Info
Lot 14190067, exp Jul-2021
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