Drug recall D-0618-2020

Class III Terminated reported Dec 18, 2019

Product

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.

Lots and codes

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

Recall details

Recalling firm
Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
Quantity
a) 34521 bottles; b) 16930 bottles
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
November 15, 2019
Terminated
March 15, 2024

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