Recalls / Class III
Class IIID-1173-2022
Product
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.
- Brand name
- Mometasone Furoate
- Generic name
- Mometasone Furoate
- Active ingredient
- Mometasone Furoate
- Route
- Topical
- NDC
- 68462-385
- FDA application
- ANDA090506
- Affected lot / code info
- 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.
Why it was recalled
Defective Container
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, N/A, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- 98, 307 packs
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-06-16
- FDA classified
- 2022-07-01
- Posted by FDA
- 2022-07-13
- Terminated
- 2026-02-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1173-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.