Drug recall D-1295-2019
Product
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.
Lots and codes
Lot #: 3200626-61, Exp 02/2022
Recall details
- Recalling firm
- MALLINCKRODT PHARMACEUTICALS, Bedminster, NJ
- Quantity
- 80,640 bottles
- Distribution
- US Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 13, 2019
- Terminated
- July 17, 2023
Related products
- Amitiza – drug information
- NDC 64764-080 Amitiza · Lubiprostone 8 ug/1 · Takeda Pharmaceuticals America, Inc.
- NDC 64764-240 Amitiza · Lubiprostone 24 ug/1 · Takeda Pharmaceuticals America, Inc.