Drug product
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.
D-1055-2020
Product summary
- Event
- Event 85169
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1,712 cartons
- Official record key
drug-enforcement:D-1055-2020
Official wording
Reason: Failed Content Uniformity Specifications: Out Of Specification test results observed for content and blend uniformity.
Code information: Lot #: L800915, Exp July 2020
Distribution pattern: Nationwide in the USA and Puerto Rico.
Derived failure modes
-
Potency or specification failure
Out Of Specification