FDA recall D-1059-2017
X-Gen Pharmaceuticals Inc. · Class II · drug
Product
Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61
Reason for recall
Presence of Foreign Substance: potential presence of plastic particles.
Distribution
Nationwide in the US
Key facts
- Status
- Terminated
- Initiation date
- 2017-05-17
- Report date
- 2017-08-16
- Termination date
- 2018-09-05
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Horseheads, NY, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1059-2017