Home / Recalls / Professional Disposables International, Inc. / D-0572-2022

D-0572-2022 Class II Terminated

Recalled by Professional Disposables International, Inc. — Orangeburg, NY

Recall Details

Product Type
Drugs
Report Date
March 2, 2022
Initiation Date
February 4, 2022
Termination Date
October 31, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
a) 28201 cases; b) 7579 cases; c) 8882 cases

Product Description

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 Pattern

Product was distributed nationwide in the USA and Puerto Rico.

Code Information

Lot #: a) 12000203, 12000204, Exp Mar 2022; 12001114 LE, Exp Jun 2022; 12001115 LE, 12001117 LE, Exp Jul 2022; 12001313, 12001407, 12001408, Exp Aug 2022; 12001498, 12001499, 12001500, 12001629, 12001630, Exp Sep 2022; 12002070, 12002114, Exp Dec 2022; 12100106, 12100107, 12100223, Exp Feb 2023; 12100224, 12100225, 12100354, 12100513, Exp Mar 2023; 12100514, 12100515, 12100605, 12100628, Exp Apr 2023; 12100629, 12100630, Exp May 2023; b) 12000332, Exp Feb 2022; 12000484, Exp Mar 2022; 12001116 LE, Exp Jul 2022; 12001312, Exp Aug 2022; 12001730, Exp Oct 2022; 12002071, 12100105, Exp Jan 2023; 12100222, Exp Mar 2023; 12100635, 12100636, Exp Jun 2023; c) 12000728, Exp Apr 2022; 12001119 LE, Exp Jul 2022; 12001631, Exp Oct 2022; 12001811, Exp Nov 2022; 12002115, 12002116, Exp Jan 2023; 12100221, Exp Feb 2023; 12100633, Exp May 2023; 12100634, 12100774, 12100817, Exp Jun 2023

Other recalls by Professional Disposables International, Inc.

  • D-0570-2022 Class II — Prevantics (chlorhexidine gluconate and isopropyl alcohol) Maxi Swabstick, 3.15% (February 4, 2022)
  • D-0571-2022 Class II — Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swab, 3.15% w/v and 7 (February 4, 2022)
  • D-0762-2021 Class II — PDI Povidone-Iodine Cleansing Scrub Swabstick (1's), 1 Swabstick, Professional D (July 23, 2021)
  • D-0763-2021 Class II — PDI Povidone-Iodide Cleansing Scrub Swabstick (3's), 3 Swabsticks, Professional (July 23, 2021)
  • D-0764-2021 Class II — PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick, (1's), Step 1, packaged (July 23, 2021)
  • D-0759-2021 Class II — PDI Povidone-Iodine Prep Pad Large, 1 Prep Pad, Professional Disposable Internat (July 23, 2021)
  • D-0761-2021 Class II — PDI Povidone-Iodine Swabstick (3's), 3 Swabsticks, Professional Disposable Inter (July 23, 2021)
  • D-0758-2021 Class II — PDI Povidone-Iodine Prep Pad MEDIUM, 1 Prep Pad [2.0x2.5 in (5.1x6.4 cm)], Profe (July 23, 2021)
  • D-0760-2021 Class II — PDI Povidine Iodine Swabstick (1's), 1 swabstick, Professional Disposable Intern (July 23, 2021)