Recall: D-0618-2020

Class III - Minor Violations

Class IIIClassification

2019-11-15Initiated

TerminatedStatus

Glenmark Pharmaceuticals Inc.,Firm

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

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.