D-0619-2020 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 18, 2019
- Initiation Date
- November 15, 2019
- Termination Date
- March 15, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 480 packs; b) 240 packs
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.
Distribution Pattern
Nationwide
Code Information
Lot 14190067, exp Jul-2021