Lupin Pharmaceuticals Inc. recalls Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.05mg/0.03 mg, 0.075mg/0.04mg, and 0.125mg/0.03mg, packaged in 1 Wal…

Recall date

March 9, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1056-2020

FDA classification

Class II

Brand / firm

Lupin Pharmaceuticals Inc.

Sold / distributed

Nationwide in the USA and Puerto Rico.

Why it was recalled

Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.05mg/0.03 mg, 0.075mg/0.04mg, and 0.125mg/0.03mg, packaged in 1 Wallet of 28 Tablets (NDC 68180-857-11), 3 Wallets of 28 Tablets Each per carton (NDC 68180-857-13); Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA.