D-1057-2019 Class II Terminated
FDA drug recall D-1057-2019 was initiated by Lupin Pharmaceuticals Inc. on March 22, 2019 and is designated Class II. Reason for recall: 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 0.01… The recall status is terminated (terminated July 1, 2020). Affected quantity: 12,464 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- April 3, 2019
- Initiation Date
- March 22, 2019
- Termination Date
- July 1, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,464 cartons
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Nationwide in the USA.
Code Information
Lot #: L800016, Exp 12/2019; L800721, Exp 05/2020