FDA recall D-1323-2022

Mckesson Medical-Surgical Inc. Corporate Office · Class II · drug

Product

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.

Distribution

Nationwide in the USA.

Key facts

Status: Terminated
Initiation date: 2022-06-29
Report date: 2022-08-17
Termination date: 2024-02-13
Voluntary/Mandated: Voluntary: Firm initiated
Location: Richmond, VA, United States

Primary source

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