An ongoing recall of Tydemy contraception by distributor Lupin Pharmaceuticals is affecting greater than 351,000 capsules bought from June 3, 2022, to May 31, 2023, the Food and Drug Administration warned customers Tuesday.

The prescription-only oral contraceptive was distributed nationwide by Lupin Pharmaceuticals, the U.S. subsidiary of the drugs’s Indian-based producer Lupin Limited.

While Lupin Pharmaceuticals initiated the recall on June 23, the initiative was solely introduced publicly by the corporate on Saturday. A selected lot labeled L200183 examined excessive in impurity and low within the inactive ingredient ascorbic acid, generally known as Vitamin C.

The lot labeled L200183 has an expiry date of January 2024. Another recalled lot, L201560, has an expiry date of September 2024. The FDA didn't specify whether or not or not L201560 was examined or why it was additionally included within the recall.

There are 4,179 bins, every containing three pouches that every include 28 capsules — a complete of 351,036 Tydemy capsules are topic to the recall. 

Lupin Pharmaceuticals mentioned it has not acquired any studies of hostile results or a failure by the drugs to work as meant linked to both of the recalled Tydemy heaps.

Content Source: www.washingtontimes.com