Why it was recalled
Labeling: label error on declared strength.
Product description
Nystatin, USP Powder for Rx compounding, 50 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0405-05, UPC 305740404058.
Lot numbers, UPCs & expiration codes
Lot #: 2015050194, Exp 2/2016
Where it was sold
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-0651-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 18, 2016
- FDA report date
- Feb 10, 2016
- Quantity
- 948 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Perrigo Company PLC
Original FDA data
Every field from FDA enforcement report D-0651-2016, exactly as published.
Show all FDA fields
- City
- Allegan
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 73101
- Address
- 515 Eastern Ave
- Code information
- Lot #: 2015050194, Exp 2/2016
- Postal code
- 49010-9070
- Report date
- Feb 10, 2016
- Product type
- Drugs
- Recall number
- D-0651-2016
- Classification
- Class II
- Recalling firm
- Perrigo Company PLC
- Product quantity
- 948 units
- Termination date
- Jun 20, 2016
- Reason for recall
- Labeling: label error on declared strength.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Nystatin, USP Powder for Rx compounding, 50 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0405-05, UPC 305740404058.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 18, 2016
- Initial firm notification
- Letter
- Center classification date
- Feb 4, 2016