D-0618-2020 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) 34521 bottles; b) 16930 bottles
Product Description
Clobetasol Propionate Foam, 0.05%, a) 50 g pack (NDC 68462-608-27) and b) 100 g pack (NDC 68462-608-94), Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No.: B-25, MIDC, Shendra Aurangabad - 431210, Maharashtra, India Manufactured for: Glenmark Pharmaceuticas 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
a) 14190026, 14190028, 14190029, exp Feb-2021, 14190043, 14190045 exp Apr-2021 b) 14190024, 14190025, 14190027, exp Feb-2021, 14190030, 14190031, exp Mar-2021, 14190039, 14190042 exp Apr-2021, 14190047 exp May-2021, 14190062 exp Jul-2021