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: Glenma

FDA recall notice · announced December 18, 2019 · Glenmark Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: Nationwide
Lot/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
Quantity: a) 34521 bottles; b) 16930 bottles
Status: Terminated
Products in this recall event:
- 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, (D-0619-2020)
- 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 Aurangaba (D-0618-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.