Drug recall D-1056-2020

Class II Terminated reported Mar 18, 2020

Product

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.

Reason for recall

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

Lots and codes

Lot #: L800951, Exp July 2020

Recall details

Recalling firm
Lupin Pharmaceuticals Inc., Baltimore, MD
Quantity
9,897 cartons
Distribution
Nationwide in the USA and Puerto Rico.
Type
Voluntary: Firm initiated
Recall initiated
March 9, 2020
Terminated
May 25, 2021

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