Recall: D-0619-2020

Class III - Minor Violations

Class IIIClassification

2019-11-15Initiated

TerminatedStatus

Glenmark Pharmaceuticals Inc.,Firm

Product

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

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

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.