May 29, 2019
An apparent labeling mix-up has prompted Mallinckrodt Pharmaceuticals to recall more than 170,000 bottles of Amitiza (lubiprostone). According to the May 29, 2019, US Food and Drug Administration (FDA) Enforcement Report, 24-mcg capsules were found in a bottle marked for 8-mcg capsules.
The recall affects 89,808 bottles of Amitiza capsules, 8 mcg, 60 count (NDC 64764-080-60), from lot 3229691-61 (Exp. 1/22). Also recalled are 80,640 bottles of Amitiza capsules, 24 mcg, 60 count (NDC 64764-240-60) from lot 3200626-61 (Exp. 2/22). The recalled bottles were distributed throughout the United States.
Mallinckrodt Pharmaceuticals voluntarily initiated the recalls May 13, 2019. On May 23, 2019, the FDA designated the recalls 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.
Amitiza is a prescription laxative used to treat chronic idiopathic constipation in adults.