FDA recall D-0571-2022

Product

Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swab, 3.15% w/v and 70% v/v, packaged as a) One Swab, 0.034 fl. Oz. (1 mL) Each in a pouch, 100 Individual Swabs per carton, 10 boxes of 100 Individual Swabs per case, REORDER NO. B10800, NDC 10819-1080-1; b) One Swab, 0.034 fl. oz. (1 mL) Each in a pouch, 3000 Individual Swabs per case, REORDER NO. B11400, NDC 10819-1080-2; 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-0571-2022