FDA-Drug2022-08-17Class II

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.

Mckesson Medical-Surgical Inc. Corporate Office
Hazard

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

Sold states
Nationwide in the USA.
Affected count
113 bottles
Manufactured in
9954 Maryland Drive, Deep Run Iii Ste. 4000, Richmond, VA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1323-2022

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