Lupin Pharmaceuticals Inc. recalls Bekyree (desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets USP, 0.01 mg), pac
Recalled March 18, 2020 · FDA recall D-1055-2020 · Lupin Pharmaceuticals
Hazard
Failed Content Uniformity Specifications: Out Of Specification test results observed for content and blend uniformity. · FDA Class III
Units
1,712 cartons
Sold at
Nationwide in the USA and Puerto Rico.
Description
Failed Content Uniformity Specifications: Out Of Specification test results observed for content and blend uniformity.
Product
Bekyree (desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets USP, 0.01 mg), packaged in 1 Wallet of 28 Tablets (NDC 68180-879-11), 3 Wallets of 28 Tablets Each per carton (NDC 68180-879-13), Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA.
Manufacturer(s)
Lupin Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →