Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61

FDA recall notice · announced August 16, 2017 · X-gen Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide in the US
Lot/code information: Lot #: 23701.158A, EXP 10/31/18
Quantity: 9,816 bottles
Status: Terminated
Products in this recall event:
- Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61 (D-1059-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.