Drug recall
Amitiza (lubiprostone) capsules, 24 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas…
FDA recall event 82830 · Class II · MALLINCKRODT PHARMACEUTICALS
Key facts
| Event ID | 82830 |
|---|---|
| Recall numbers | D-1294-2019, D-1295-2019 |
| Recalling firm | MALLINCKRODT PHARMACEUTICALS |
| Product type | Drugs |
| Products | Amitiza (lubiprostone) capsules, 24 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-240-60, Amitiza (lubiprostone) capsules, 8 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-080-60 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | May 13, 2019 |
| Report date | May 29, 2019 |
| Termination date | Jul 17, 2023 |
| City | Bedminster |
| State | NJ |
| Country | United States |
| FEI number | 3014664326 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: