Why it was recalled
Defective Container
Product description
Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a) 30 ml-bottle (NDC 68462-385-37), b) 60 ml-bottle (NDC 68462-385-02), Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Baddi Himachal Pradesh 173205, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah NJ 07430.
Lot numbers, UPCs & expiration codes
Lot # a) 05201358, Exp 06/2022; 05210287, 05210288, Exp 01/2023; 05211446, Exp 07/2023; 05211704, 05211714, Exp 08/2023; 05212217, Exp 10/2023: b) 05201358, Exp 06/2022; 05210287, 05210288, 05210424, Exp 01/2023; 05210425, 05210435, Exp 02/2023; 05211427, 05211439, 05211445, Exp 07/2023; 05211723, 05211731, 05211850, 05211864, Exp 08/2023; 05212226, 05212250, 05212261, Exp 10/2023.
Where it was sold
Nationwide in the USA
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-1173-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 16, 2022
- FDA report date
- Jul 13, 2022
- Quantity
- 98, 307 packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
Original FDA data
Every field from FDA enforcement report D-1173-2022, exactly as published.
Show all FDA fields
- City
- Mahwah
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 90473
- Address
- 750 Corporate Dr
- Code information
- Lot # a) 05201358, Exp 06/2022; 05210287, 05210288, Exp 01/2023; 05211446, Exp 07/2023; 05211704, 05211714, Exp 08/2023; 05212217, Exp 10/2023: b) 05201358, Exp 06/2022; 05210287, 05210288, 05210424, Exp 01/2023; 05210425, 05210435, Exp 02/2023; 05211427, 05211439, 05211445, Exp 07/2023; 05211723, 05211731, 05211850, 05211864, Exp 08/2023; 05212226, 05212250, 05212261, Exp 10/2023.
- Postal code
- 07430-2009
- Report date
- Jul 13, 2022
- Product type
- Drugs
- Recall number
- D-1173-2022
- Classification
- Class III
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Product quantity
- 98, 307 packs
- Termination date
- Feb 24, 2026
- Reason for recall
- Defective Container
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a) 30 ml-bottle (NDC 68462-385-37), b) 60 ml-bottle (NDC 68462-385-02), Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Baddi Himachal Pradesh 173205, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah NJ 07430.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jun 16, 2022
- Initial firm notification
- Letter
- Center classification date
- Jul 1, 2022