Amitiza (lubiprostone) capsules, 24 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-240-60
Check against the official notice below — it lists the full affected range.
Mallinckrodt Pharmaceuticals is recalling Amitiza (lubiprostone) capsules due to a labeling mix-up affecting 80,640 bottles distributed nationwide. Some bottles labeled as containing 8 mcg capsules actually contained 24 mcg capsules, while some bottles labeled as containing 24 mcg capsules actually contained only 8 mcg capsules. The affected product is Lot #3200626-61 with an expiration date of 02/2022, manufactured by Sucampo Pharma Americas, LLC.
The recall notice does not specify a remedy or instructions for what affected consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, this incident is being considered as a labeling mix-up issue.
Reason for recall: Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, this incident is being considered as a labeling mix-up issue. Distribution: US Nationwide Quantity: 80,640 bottles Lot/code info: Lot #: 3200626-61, Exp 02/2022
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.