Drug product
Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61
D-1059-2017
Product summary
- Event
- Event 77834
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9,816 bottles
- Official record key
drug-enforcement:D-1059-2017
Official wording
Reason: Presence of Foreign Substance: potential presence of plastic particles.
Code information: Lot #: 23701.158A, EXP 10/31/18
Distribution pattern: Nationwide in the US
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance