Amitiza (lubiprostone) capsules, 8 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-080-60
Reported: May 29, 2019 Initiated: May 13, 2019 #D-1294-2019
Product Description
Amitiza (lubiprostone) capsules, 8 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-080-60
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.
Details
- Recalling Firm
- MALLINCKRODT PHARMACEUTICALS
- Units Affected
- 89,808 bottles
- Distribution
- US Nationwide
- Location
- Bedminster, NJ
Frequently Asked Questions
What product was recalled? ▼
Amitiza (lubiprostone) capsules, 8 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-080-60. Recalled by MALLINCKRODT PHARMACEUTICALS. Units affected: 89,808 bottles.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 29, 2019. Severity: Moderate. Recall number: D-1294-2019.
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