MOMETASONE FUROATE Recall D-1173-2022
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.
MOMETASONE FUROATE Recall D-1173-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1173-2022 |
| Event ID | 90473 |
| Brand | MOMETASONE FUROATE |
| Generic Name | MOMETASONE FUROATE |
| Manufacturer | MOMETASONE FUROATE |
| Original Package? | 1 |
| Active Substance | MOMETASONE FUROATE |
| Drug Route | TOPICAL |
| Distribution | Nationwide in the USA |
| Quantity | 98, 307 packs |
| Recall Reason | Defective Container |
| Drug Classification | Class III |
| Drug Code Info | 20220713 |
| Product NDC | 68462-385 |
| Drug UPC | 0368462385371 |
| Recall Initiation Date | 20220616 |
| Report Date | 20220713 |
| Classification Date | 20220701 |
| Address | 750 Corporate Dr Mahwah, NJ 07430-2009 United States |
| Recalling Firm | Glenmark Pharmaceuticals Inc., USA |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 04201GDN4R |
| Drug Application Number | ANDA090506 |
| Structured Product Labeling (SPL ID) | 126901b5-73a3-477a-81f2-61a373806f7f |
| Structured Product Labeling (SPL Set ID) | 96eafc06-0354-49ca-a684-a77bb2afc8f5 |
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