FDA recall D-0572-2022

Product

Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swabstick, 3.15% w/v and 70% v/v, packaged as a) One Swabstick, 0.054 fl. oz. (1.6 mL) Each in a pouch, NDC 10819-4077-1; 50 Individual Swabsticks per carton, 10 boxes of 50 Individual Swabsticks per case, REORDER NO. S40750, NDC 10819-4077-4; b) One Swabstick, 0.054 fl. Oz. (1.6 mL) Each in a pouch, 500 Individual Swabsticks per case, REORDER NO. S32450, NDC 10819-4077-2; c) One Swabstick, 0.054 fl. Oz. (1.6 mL) Each in a pouch, 500 Individual Swabsticks per case, REORDER NO. S42850, NDC 10819-4077-3; 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-0572-2022