PlainRecalls
FDA Drug Moderate Class II Terminated

HySept Solution 0.25% Sodium Hypochlorite Solution 473 mL (16 fl. oz.) NDC 39328-063-25 Manufactured in USA Patrin Pharma, Skokie, IL 60076

Reported: June 2, 2021 Initiated: March 15, 2021 #D-0540-2021

Product Description

HySept Solution 0.25% Sodium Hypochlorite Solution 473 mL (16 fl. oz.) NDC 39328-063-25 Manufactured in USA Patrin Pharma, Skokie, IL 60076

Reason for Recall

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Details

Recalling Firm
Cardinal Health Inc.
Units Affected
236 bottles
Distribution
FL, GA, SC
Location
Dublin, OH

Frequently Asked Questions

What product was recalled?
HySept Solution 0.25% Sodium Hypochlorite Solution 473 mL (16 fl. oz.) NDC 39328-063-25 Manufactured in USA Patrin Pharma, Skokie, IL 60076. Recalled by Cardinal Health Inc.. Units affected: 236 bottles.
Why was this product recalled?
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 2, 2021. Severity: Moderate. Recall number: D-0540-2021.