FDA recall D-0070-2018

Product

Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP. Stamford, CT 06901-3431 NDC 67618-153-01

Reason for recall

Subpotent Drug: The laminate used to make the pouches was reversed such that the aluminum layer was in contact with the product causing an exothermic reaction between the free iodine and the aluminum.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2017-10-05

Report date

2017-11-15

Termination date

2020-01-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Stamford, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0070-2018