Mometasone Furoate Topical Solution, USP, 0.1%, (Lotion), a) 30 mL (NDC 0713-0701-85) and b) 60 mL (NDC 0713-0701-53), Rx Only, Distributed by: Cosette Pharmaceuticals, Inc., South Plainfield, NJ 07080
Reported: April 14, 2021 Initiated: March 25, 2021 #D-0327-2021
Product Description
Mometasone Furoate Topical Solution, USP, 0.1%, (Lotion), a) 30 mL (NDC 0713-0701-85) and b) 60 mL (NDC 0713-0701-53), Rx Only, Distributed by: Cosette Pharmaceuticals, Inc., South Plainfield, NJ 07080
Reason for Recall
CGMP Deviaitons
Details
- Recalling Firm
- Cosette Pharmaceuticals, Inc.
- Units Affected
- a) 30 mL: 7724 b) 60 mL: 8064 bottles
- Distribution
- Nationwide in the US
- Location
- South Plainfield, NJ
Frequently Asked Questions
What product was recalled? ▼
Mometasone Furoate Topical Solution, USP, 0.1%, (Lotion), a) 30 mL (NDC 0713-0701-85) and b) 60 mL (NDC 0713-0701-53), Rx Only, Distributed by: Cosette Pharmaceuticals, Inc., South Plainfield, NJ 07080. Recalled by Cosette Pharmaceuticals, Inc.. Units affected: a) 30 mL: 7724 b) 60 mL: 8064 bottles.
Why was this product recalled? ▼
CGMP Deviaitons
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 14, 2021. Severity: Moderate. Recall number: D-0327-2021.
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