Lupinâ„¢s U.S. arm recalls contraceptive after out of specifications results

August 02, 2023,

The U.S. arm of drugmaker Lupin, which said two generic drugs, including an oral contraceptive, had received U.S. FDA’s approval, is recalling two batches of Tydemy, an estrogen/progestin oral contraceptive, due to out-of-specification results at the 12-month stability time point.

Specifically, one lot (L200183) tested low for ascorbic acid (an inactive ingredient) and high for a known impurity.

Lupin Pharmaceuticals Inc. is voluntarily recalling them since the significant reduction in the amount of inactive content (ascorbic acid) could potentially impact the effectiveness of the product, U.S. FDA said following the firm’s July 29 notification. The affected lots had been distributed from June 3, 2022, to May 31, 2023.

Parent company Lupin on Tuesday said its abbreviated new drug application to market Turqoz (Norgestrel and Ethinyl Estradiol Tablets USP) 0.3 mg/0.03 mg, a generic equivalent of Wyeth Pharmaceuticals’ oral contraceptive Lo/Ovral-28 (Norgestrel and Ethinyl Estradiol Tablets) 0.3 mg/0.03 mg, had received U.S. FDA approval and the product would be manufactured at the Pithampur facility.

On Wednesday, it said wholly owned subsidiary Novel Laboratories Inc., based in Somerset, New Jersey, had received U.S. FDA approval for its ANDA for Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil), a generic equivalent of Hill Dermaceuticals Inc.’s Derma-Smoothe/FS Topical Oil, 0.01% (Scalp Oil). The product will be manufactured at Lupin’s Somerset facility in the US. Lupin shares closed less than 1% higher at ₹993.90 each on the BSE.

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