Why it was 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.
Product description
Amitiza (lubiprostone) capsules, 8 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-080-60
Lot numbers, UPCs & expiration codes
Lot #: 3229691-61, Exp 01/2022
Where it was sold
US Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1294-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 13, 2019
- FDA report date
- May 29, 2019
- Quantity
- 89,808 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- MALLINCKRODT PHARMACEUTICALS
Original FDA data
Every field from FDA enforcement report D-1294-2019, exactly as published.
Show all FDA fields
- City
- Bedminster
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 82830
- Address
- 1425 Us Highway 206
- Code information
- Lot #: 3229691-61, Exp 01/2022
- Postal code
- 07921-2653
- Report date
- May 29, 2019
- Product type
- Drugs
- Recall number
- D-1294-2019
- Classification
- Class II
- Recalling firm
- MALLINCKRODT PHARMACEUTICALS
- Product quantity
- 89,808 bottles
- Termination date
- Jul 17, 2023
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Amitiza (lubiprostone) capsules, 8 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-080-60
- Distribution pattern
- US Nationwide
- Recall initiation date
- May 13, 2019
- Initial firm notification
- Letter
- Center classification date
- May 23, 2019