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.

This recall has been terminated (originally issued April 3, 2019).

Company

Lupin Pharmaceuticals Inc.

Recall Initiated

March 22, 2019

Posted

April 3, 2019

Recall Number

D-1057-2019

Voluntary / Mandated

Voluntary: Firm initiated

Quantity

12,464 cartons

Firm Location

Baltimore, MD, United States

Official Source

View on FDA website ↗