TACROLIMUS Recall D-1304-2022
Description: Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC 68462-534-35, b) 60 g tube, NDC 68462-534-65, c) 100 g tube, NDC 68462-534-94, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India.
TACROLIMUS Recall D-1304-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1304-2022 |
| Event ID | 90550 |
| Brand | TACROLIMUS |
| Generic Name | TACROLIMUS |
| Manufacturer | TACROLIMUS |
| Original Package? | 1 |
| Active Substance | TACROLIMUS |
| Drug Route | TOPICAL |
| Distribution | Nationwide in the USA |
| Quantity | 654,756 tubes |
| Recall Reason | Defective Container: Tube split from side seam |
| Drug Classification | Class III |
| Drug Code Info | 20220810 |
| Product NDC | 68462-534 |
| Drug UPC | 0368462534946 |
| Recall Initiation Date | 20220711 |
| Report Date | 20220810 |
| Classification Date | 20220804 |
| Address | 750 Corporate Dr Mahwah, NJ 07430-2009 United States |
| Recalling Firm | Glenmark Pharmaceuticals Inc., USA |
| Initial Notification | Letter |
| Unique Ingredient Identifier | WM0HAQ4WNM |
| Drug Application Number | ANDA210393 |
| Structured Product Labeling (SPL ID) | cc97f54d-975c-4807-92bd-3558c221dc05 |
| Structured Product Labeling (SPL Set ID) | c2d2e3a1-f346-4245-b445-6dd44e371180 |
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