Why it was recalled
CGMP Deviations: Market complaints related to "gritty texture".
Product description
Glenmark Mometasone Furoate Cream, USP, 0.1%, 45 g Rx Only Manufactured by: Glenmark Pharmaceuticals Ltd. Village Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 NDC 68462019255 UPC 3684620192559
Lot numbers, UPCs & expiration codes
Batch Number: 05170598; Exp. 03/19
Where it was sold
Product was distributed throughout the United States.
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-0336-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 20, 2017
- FDA report date
- Feb 7, 2018
- Quantity
- 5136 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
Original FDA data
Every field from FDA enforcement report D-0336-2018, exactly as published.
Show all FDA fields
- City
- Mahwah
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 78605
- Address
- 750 Corporate Dr
- Code information
- Batch Number: 05170598; Exp. 03/19
- Postal code
- 07430-2009
- Report date
- Feb 7, 2018
- Product type
- Drugs
- Recall number
- D-0336-2018
- Classification
- Class II
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Product quantity
- 5136 tubes
- Termination date
- Oct 3, 2018
- Reason for recall
- CGMP Deviations: Market complaints related to "gritty texture".
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Glenmark Mometasone Furoate Cream, USP, 0.1%, 45 g Rx Only Manufactured by: Glenmark Pharmaceuticals Ltd. Village Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 NDC 68462019255 UPC 3684620192559
- Distribution pattern
- Product was distributed throughout the United States.
- Recall initiation date
- Nov 20, 2017
- Initial firm notification
- Letter
- Center classification date
- Feb 7, 2018