Amitiza (lubiprostone) capsules, 8 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-080-60
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 both the 8 mcg and 24 mcg strengths. Specifically, some bottles labeled as containing 8 mcg capsules were found to actually contain 24 mcg capsules, while at least one sealed bottle labeled as 24 mcg was found to contain only 8 mcg capsules. The recall involves 89,808 bottles distributed nationwide, specifically Lot #3229691-61 with an expiration date of January 2022.
The recall poses a potential safety concern because patients receiving the incorrect dosage strength could experience unintended effects. The source document 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: 89,808 bottles Lot/code info: Lot #: 3229691-61, Exp 01/2022
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.