Glenmark Pharmaceuticals Inc., USA: 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. Plo

Is my product affected?

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

• Brand CLOBETASOL PROPIONATE

Check against the official notice below — it lists the full affected range.

What happened

Glenmark Pharmaceuticals Inc. is recalling Clobetasol Propionate Foam, 0.05%, in both 50-gram and 100-gram sizes distributed nationwide. The recall affects specific lot codes with expiration dates ranging from February 2021 through July 2021, totaling 51,451 bottles. The foam has a defective delivery system that causes the product to come out as liquid instead of foam.

The source document does not specify what affected consumers should do regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Defective delivery system; product is not foaming or is coming out as liquid.

Details from the source

Reason for recall: Defective delivery system; product is not foaming or is coming out as liquid. Distribution: Nationwide Quantity: a) 34521 bottles; b) 16930 bottles Lot/code info: 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

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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