April 04, 2019
Lupin Pharmaceuticals Inc. is recalling 12,464 cartons of Fayosim tablets after out-of-specification results were observed for an impurity, according to the April 3, 2019, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects Fayosim (levonorgestrel and ethinyl estradiol) tablets (0.15 mg/0.02 mg, 0.15 mg/0.025 mg, 0.15 mg/0.03 mg) and ethinyl estradiol tablets (0.01 mg) packaged in an extended-cycle wallet of 91 tablets packed in a pouch (NDC 68180-860-11), one pouch per carton (NDC 68180-860-12), from two lots: L800016 (Exp. 12/19) and L800721 (Exp. 5/20). The recalled Fayosim was distributed throughout the United States.
Lupin Pharmaceuticals voluntarily initiated the recall March 22, 2019. On March 25, 2019, the FDA designated it Class II, signaling use of the affected tablets could cause temporary or medically reversible adverse health consequences. Although the likelihood is remote, a possibility of serious harm also exists.
Fayosim is a prescription hormonal contraceptive.