Recall D-1081-2023
Description: Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets 0.451 mg), packaged in 1 blister of 28 tablets each (NDC 68180-904-71) further packaged in a carton of 3 blisters (NDC 68180-904-73), Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by Lupin Limited, Pithampur (M.P.), INDIA
Recall D-1081-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1081-2023 |
| Event ID | 92588 |
| Brand | TYDEMY |
| Generic Name | DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM |
| Manufacturer | DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM |
| Original Package? | 1 |
| Distribution | USA nationwide. |
| Quantity | 4,179 boxes/_ cartons per box/3 pouches each/28 blister per pouch |
| Recall Reason | Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test |
| Drug Classification | Class I |
| Drug Code Info | 20230809 |
| Product NDC | 68180-904 |
| Drug UPC | 0368180904717 |
| Recall Initiation Date | 20230623 |
| Report Date | 20230809 |
| Classification Date | 20230804 |
| Address | Harborplace Tower111 S Calvert St Fl 21st Baltimore, MD 21202-6174 United States |
| Recalling Firm | Lupin Pharmaceuticals Inc. |
| Initial Notification | Letter |
| Drug Application Number | ANDA205948 |
| Structured Product Labeling (SPL ID) | 841f0af7-6db1-4aad-bd04-6d1f71544ab0 |
| Structured Product Labeling (SPL Set ID) | e4766132-4faa-4f76-89fe-75d4a6fd737b |
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