Professional Disposables International, Inc.: Drug Recall
Recall #D-0571-2022 · 02/04/2022
Class II: Risk
Recall Details
- Recall Number
- D-0571-2022
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Professional Disposables International, Inc.
- Status
- Terminated
- Date Initiated
- 02/04/2022
- Location
- Orangeburg, NY, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 160531 cases; b) 16123 cases
Reason for Recall
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
Product Description
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.
Distribution Pattern
Product was distributed nationwide in the USA and Puerto Rico.
Other Recalls by Professional Disposables International, Inc.
- Class II: Risk 02/04/2022
- Class II: Risk 02/04/2022
- Class II: Risk 07/23/2021
- Class II: Risk 07/23/2021
- Class II: Risk 07/23/2021
View all recalls by Professional Disposables International, Inc. →
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.