FDA recall D-1315-2022

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

Product

Eye-stream, eye wash solution, sterile, 4 FL OZ (118 mL) bottle per box, Alcon, NDC 0065-0530-04.

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-1315-2022