Recalls / Class II
Class IID-0651-2016
Product
Nystatin, USP Powder for Rx compounding, 50 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0405-05, UPC 305740404058.
- Affected lot / code info
- Lot #: 2015050194, Exp 2/2016
Why it was recalled
Labeling: label error on declared strength.
Recalling firm
- Firm
- Perrigo Company PLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 515 Eastern Ave, N/A, Allegan, Michigan 49010-9070
Distribution
- Quantity
- 948 units
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-01-18
- FDA classified
- 2016-02-04
- Posted by FDA
- 2016-02-10
- Terminated
- 2016-06-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0651-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.