Bekyree (desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl estradiol tab...
FDA Recall #D-1055-2020 — Class III — March 9, 2020
Product Description
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.
Reason for Recall
Failed Content Uniformity Specifications: Out Of Specification test results observed for content and blend uniformity.
Recalling Firm
Lupin Pharmaceuticals Inc. — Baltimore, MD
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
1,712 cartons
Distribution
Nationwide in the USA and Puerto Rico.
Code Information
Lot #: L800915, Exp July 2020
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated