Recalls / Class III
Class IIID-0618-2020
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
- Brand name
- Clobetasol Propionate
- Generic name
- Clobetasol Propionate
- Active ingredient
- Clobetasol Propionate
- Route
- Topical
- NDC
- 68462-608
- FDA application
- ANDA210809
- Affected 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
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) 34521 bottles; b) 16930 bottles
- 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-0618-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.