D-1056-2020 Class II Terminated
FDA drug recall D-1056-2020 was initiated by Lupin Pharmaceuticals Inc. on March 9, 2020 and is designated Class II. Reason for recall: Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity. The recall status is terminated (terminated May 25, 2021). Affected quantity: 9,897 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
- 9,897 cartons
Product Description
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.
Distribution Pattern
Nationwide in the USA and Puerto Rico.
Code Information
Lot #: L800951, Exp July 2020