D-1295-2019 Class II Terminated
FDA drug recall D-1295-2019 was initiated by MALLINCKRODT PHARMACEUTICALS on May 13, 2019 and is designated Class II. 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. … The recall status is terminated (terminated July 17, 2023). Affected quantity: 80,640 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 29, 2019
- Initiation Date
- May 13, 2019
- Termination Date
- July 17, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 80,640 bottles
Product Description
Amitiza (lubiprostone) capsules, 24 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-240-60
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 Pattern
US Nationwide
Code Information
Lot #: 3200626-61, Exp 02/2022