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Stability and Purity Issues Lead to Recall of Tydemy
One of the two recalled lots of the birth control tested high for a known impurity.
Lupin Pharmaceuticals is voluntarily recalling two lots of Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium), because of results of a 12-month stability test. Additionally, one lot tested low for ascorbic acid (an inactive ingredient) and high for a known impurity.
Tydemy is estrogen/progestin oral contraceptive used to prevent pregnancy. Lupin is recalling two lots because the reduction in the amount of inactive ingredient could potentially impact the effectiveness of the product and potentially result in unexpected pregnancy.
The lots were distributed nationwide in the United States to wholesalers, drug chains, mail order pharmacies and supermarkets.
The recalled lots have an NDC of 68180-904-71 for one blister packs of 28 tablets each and 68180-904-73 for three blister packs of 28 tablets each. Lot number L200183 has an expiration date of January 2024, and lot number L201560 has an expiration date of September 2024. Both lots were distributed between June 2022 and May 2023.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
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FDA Approves Stelara Biosimilar, Selarsdi
April 18th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
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