Medicine recalls
|
| |
| The United States: Lupin Pharmaceuticals, Inc. issues voluntary nationwide recall of 2 lots of Tydemy due to out of specification (OOS) results at the 12-month stability time point |
| |
The US Food and Drug Administration (FDA) announces that Lupin Pharmaceuticals, Inc. (Lupin) is voluntarily recalling 2 lots (lot number: L200183, L201560) of Tydemy (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets 3mg/0.03mg/0.451mg and Levomefolate Calcium Tablets 0.451mg) to the patient (consumer/user) level due to out of specification (OOS) test results at the 12-month stability time point. Specifically, one lot (lot number: L200183) tested low for ascorbic acid (an inactive ingredient) and high for a known impurity.
To date, Lupin has received no reports of adverse events related to either recalled lots. Regardless, Lupin is recalling these 2 lots because if there were a significant reduction in the amount of inactive content (ascorbic acid), this could potentially impact the effectiveness of the product which could potentially result in unexpected pregnancy.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lupin-pharmaceuticals-inc-issues-voluntary-nationwide-recall-2-lots-tydemytm-drospirenone-ethinyl
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Tuesday, Aug 1, 2023
Issued at HKT 15:00
|
| |
