FDA recall D-0570-2022

Product

Prevantics (chlorhexidine gluconate and isopropyl alcohol) Maxi Swabstick, 3.15% w/v and 70% v/v, packaged as a) One Maxi Swabstick, 0.172 fl. Oz. (5.1 mL) Each in a pouch, 30 Individual Maxi Swabsticks per carton, 10 boxes of 30 Individual Swabsticks per case, NDC 10819-4076-4, REORDER NO. S41950; b) One Maxi Swabstick, 0.172 fl. Oz. (5.1 mL) Each in a pouch, 300 Individual Swabsticks per case, NDC 10819-4076-3, REORDER NO. S27350; Professional Disposables International, Inc., Orangeburg, NY 10962-1376.

Reason for recall

cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.

Distribution

Product was distributed nationwide in the USA and Puerto Rico.

Key facts

Status

Terminated

Initiation date

2022-02-04

Report date

2022-03-02

Termination date

2023-10-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Orangeburg, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0570-2022