Recalls / Class II
Class IID-1059-2017
Product
Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61
- Affected lot / code info
- Lot #: 23701.158A, EXP 10/31/18
Why it was recalled
Presence of Foreign Substance: potential presence of plastic particles.
Recalling firm
- Firm
- X-Gen Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 300 Daniel Zenker Dr, N/A, Horseheads, New York 14845-1014
Distribution
- Quantity
- 9,816 bottles
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2017-05-17
- FDA classified
- 2017-08-09
- Posted by FDA
- 2017-08-16
- Terminated
- 2018-09-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1059-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.