PlainRecalls
FDA Drug Moderate Class II Terminated

Dakin's Solution, a) sodium hypochlorite 0.125%, quarter strength, NDC 0436-0672-16, b) sodium hypochlorite 0.25%, half strength, NDC 0436-0936-16, c) sodium hypochlorite 0.5% full strength, NDC 0436-0946-16, Antimicrobial, 473 mL (16 fl oz) bottle, Century Pharmaceuticals, Inc.

Reported: August 17, 2022 Initiated: June 29, 2022 #D-1323-2022

Product Description

Dakin's Solution, a) sodium hypochlorite 0.125%, quarter strength, NDC 0436-0672-16, b) sodium hypochlorite 0.25%, half strength, NDC 0436-0936-16, c) sodium hypochlorite 0.5% full strength, NDC 0436-0946-16, Antimicrobial, 473 mL (16 fl oz) bottle, Century Pharmaceuticals, Inc.

Reason for Recall

CGMP Deviations: products were stored outside the drug label specifications.

Details

Units Affected
113 bottles
Distribution
Nationwide in the USA.
Location
Richmond, VA

Frequently Asked Questions

What product was recalled?
Dakin's Solution, a) sodium hypochlorite 0.125%, quarter strength, NDC 0436-0672-16, b) sodium hypochlorite 0.25%, half strength, NDC 0436-0936-16, c) sodium hypochlorite 0.5% full strength, NDC 0436-0946-16, Antimicrobial, 473 mL (16 fl oz) bottle, Century Pharmaceuticals, Inc.. Recalled by Mckesson Medical-Surgical Inc. Corporate Office. Units affected: 113 bottles.
Why was this product recalled?
CGMP Deviations: products were stored outside the drug label specifications.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 17, 2022. Severity: Moderate. Recall number: D-1323-2022.