Recalls / Class III
Class IIID-0619-2020
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
- Brand name
- Clobetasol Propionate
- Generic name
- Clobetasol Propionate
- Active ingredient
- Clobetasol Propionate
- Route
- Topical
- NDC
- 68462-625
- FDA application
- ANDA211450
- Affected lot / code info
- Lot 14190067, exp Jul-2021
Why it was recalled
Defective delivery system; product is not foaming or is coming out as liquid.
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, N/A, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- a) 480 packs; b) 240 packs
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2019-11-15
- FDA classified
- 2019-12-10
- Posted by FDA
- 2019-12-18
- Terminated
- 2024-03-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0619-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.