August 09, 2019
Lupin Pharmaceuticals Inc. is recalling a single lot of Kaitlib Fe (norethindrone and ethinyl estradiol [0.8 mg/0.025 mg] and ferrous fumarate) chewable tablets (blister pack NDC 68180-903-11, carton containing three blister packs NDC 68180-903-13). The recall was prompted by an out-of-specification result obtained during long-term stability testing, according to the August 7, 2019, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects Kaitlib Fe tablets from lot L800050. The tablets were distributed throughout the United States.
Lupin Pharmaceuticals Inc. voluntarily initiated the recall July 2, 2019. On July 30, 2019, the FDA designated the recall Class II. The classification suggests use of the product could cause temporary or medically reversible adverse health consequences. Although the likelihood is remote, a possibility of serious harm also exists.
Kaitlib Fe is a prescription oral contraceptive.