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
Reported: December 18, 2019 Initiated: November 15, 2019 #D-0618-2020
Product Description
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 for Recall
Defective delivery system; product is not foaming or is coming out as liquid.
Details
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Units Affected
- a) 34521 bottles; b) 16930 bottles
- Distribution
- Nationwide
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Glenmark Pharmaceuticals Inc., USA. Units affected: a) 34521 bottles; b) 16930 bottles.
Why was this product recalled? ▼
Defective delivery system; product is not foaming or is coming out as liquid.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 18, 2019. Severity: Low. Recall number: D-0618-2020.
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