Drug 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.
D-1056-2020
Product summary
- Event
- Event 85169
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9,897 cartons
- Official record key
drug-enforcement:D-1056-2020
Official wording
Reason: Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity.
Code information: Lot #: L800951, Exp July 2020
Distribution pattern: Nationwide in the USA and Puerto Rico.
Derived failure modes
-
Potency or specification failure
Out Of Specification