TACROLIMUS Recall D-0330-2023
Description: Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Reddy's Laboratories Limited, Bachupally - 500 090, INDIA; NDC 55111-525-01.
TACROLIMUS Recall D-0330-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0330-2023 |
| Event ID | 91661 |
| Brand | TACROLIMUS |
| Generic Name | TACROLIMUS |
| Manufacturer | TACROLIMUS |
| Original Package? | 1 |
| Active Substance | TACROLIMUS |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA |
| Quantity | 4,320 bottles |
| Recall Reason | Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules. |
| Drug Classification | Class II |
| Drug Code Info | 20230301 |
| Product NDC | 55111-525 55111-526 55111-527 |
| Drug UPC | 0355111526018 0355111525011 0355111527015 |
| Recall Initiation Date | 20230208 |
| Report Date | 20230301 |
| Classification Date | 20230221 |
| Address | 107 College Rd E Princeton, NJ 08540-6623 United States |
| Recalling Firm | Dr. Reddy's Laboratories, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | WM0HAQ4WNM |
| Drug Application Number | ANDA090509 |
| Structured Product Labeling (SPL ID) | 1f9cc1ab-687d-eb66-9b7f-867cca0600fb |
| Structured Product Labeling (SPL Set ID) | 61dee012-43af-0e9a-3843-9b9b91e022c4 |
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