Reported Dec 18, 2019 · Terminated
Clobetasol Propionate Foam, 0.05%, a) 50 g pack (NDC 68462-608-27) and b) 100 g pack (NDC 68462-608-94), Rx only,…
Glenmark Pharmaceuticals Inc., USA
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Glenmark Pharmaceuticals Inc., USA · 750 Corporate Dr · Mahwah, NJ · 07430-2009
Is this the product you have?
- 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 byGlenmark Pharmaceuticals Ltd. Plot No.: B-25, MIDC, Shendra Aurangabad - 431210, Maharashtra
- India Manufactured forGlenmark Pharmaceuticas Inc. USA Mahwah, NJ 07430
- Lot codes and dates
a) 141900261419002814190029exp Feb-20211419004314190045 exp Apr-2021 b) 141900241419002514190027exp Feb-20211419003014190031exp Mar-20211419003914190042 exp Apr-202114190047 exp May-202114190062 exp Jul-2021
- Amount recalled
- a) 34521 bottles; b) 16930 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Defective delivery system; product is not foaming or is coming out as liquid.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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