Drug product
Fayosim (levonorgestrel and ethinyl estradiol) tablets USP, (0.15 mg/0.02 mg, 0.15 mg/0.025 mg, 0.15 mg/0.03 mg) and ethinyl estradiol tablets USP, (0.01 mg), packaged in 1 Extended-Cycle Wallet of 91 Tablets packed in a pouch(NDC 68180-860-11); one pouch per carton (NDC 68180-860-12), Rx only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA.
D-1057-2019
Product summary
- Event
- Event 82356
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12,464 cartons
- Official record key
drug-enforcement:D-1057-2019
Official wording
Reason: Failed Impurities/Degradation Specifications: Out-of-specification results observed in related substance test (Any Other Individual Impurity and Total impurities) in Ethinyl Estradiol Tablets USP 0.01mg at 12 month long term stability study.
Code information: Lot #: L800016, Exp 12/2019; L800721, Exp 05/2020
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Out-of-specification