D-1055-2020 Class III Terminated
FDA drug recall D-1055-2020 was initiated by Lupin Pharmaceuticals Inc. on March 9, 2020 and is designated Class III. Reason for recall: Failed Content Uniformity Specifications: Out Of Specification test results observed for content and blend uniformity. The recall status is terminated (terminated May 25, 2021). Affected quantity: 1,712 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- March 18, 2020
- Initiation Date
- March 9, 2020
- Termination Date
- May 25, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,712 cartons
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.
Distribution Pattern
Nationwide in the USA and Puerto Rico.
Code Information
Lot #: L800915, Exp July 2020