Why it was recalled
CGMP Deviaitons
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
Lot numbers, UPCs & expiration codes
a) 30 mL: 1014611 and 1014612, exp 12/2022 b) 60 mL:1014593, 1014594 and 1014595, exp 10/2022
Where it was sold
Nationwide in the US
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0327-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 25, 2021
- FDA report date
- Apr 14, 2021
- Quantity
- a) 30 mL: 7724 b) 60 mL: 8064 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Cosette Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0327-2021, exactly as published.
Show all FDA fields
- City
- South Plainfield
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 87608
- Address
- 111 Coolidge St
- Code information
- a) 30 mL: 1014611 and 1014612, exp 12/2022 b) 60 mL:1014593, 1014594 and 1014595, exp 10/2022
- Postal code
- 07080-3801
- Report date
- Apr 14, 2021
- Product type
- Drugs
- Recall number
- D-0327-2021
- Classification
- Class II
- Recalling firm
- Cosette Pharmaceuticals, Inc.
- Product quantity
- a) 30 mL: 7724 b) 60 mL: 8064 bottles
- Termination date
- Jul 17, 2023
- Reason for recall
- CGMP Deviaitons
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Mar 25, 2021
- Initial firm notification
- Letter
- Center classification date
- Apr 7, 2021