Drug recall
Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and…
FDA recall event 92588 · Class I · Lupin Pharmaceuticals Inc.
Key facts
| Event ID | 92588 |
|---|---|
| Recall numbers | D-1081-2023 |
| Recalling firm | Lupin Pharmaceuticals Inc. |
| Product type | Drugs |
| Products | 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)… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test |
| Initiation date | Jun 23, 2023 |
| Report date | Aug 9, 2023 |
| Termination date | Jan 28, 2025 |
| City | Baltimore |
| State | MD |
| Country | United States |
| FEI number | 3004097115 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: