PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: August 16, 2017 Initiated: May 17, 2017 #D-1059-2017

Product Description

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.

Details

Units Affected
9,816 bottles
Distribution
Nationwide in the US
Location
Horseheads, NY

Frequently Asked Questions

What product was recalled?
Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61. Recalled by X-Gen Pharmaceuticals Inc.. Units affected: 9,816 bottles.
Why was this product recalled?
Presence of Foreign Substance: potential presence of plastic particles.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 16, 2017. Severity: Moderate. Recall number: D-1059-2017.