Lupin Pharmaceuticals Inc. Recall: Tydemy (drospirenone, ethinyl estradiol and levomefolat
Lupin Pharmaceuticals Inc. Recall: Tydemy (drospirenone, ethinyl estradiol and levomefolat is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Lupin Pharmaceuticals Inc.; Product: Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefola
| Recalling firm | Lupin Pharmaceuticals Inc. |
|---|---|
| Product | 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 |
| Reason for recall | Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test |
| Classification | Class I (most serious — reasonable probability of serious health consequences or death) |
| Status | Terminated |
| Distribution | USA nationwide. |
| Recall initiated | 20230623 |
| Recall number | D-1081-2023 |
| Category | drug |
| State | MD |
| Country | United States |
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