Multi-event February 2022 FDA Recall Prevantics Swab by Professional Disposables International, Inc.
This Multi-event Class II drug recall was voluntarily initiated by Professional Disposables International, Inc. on February 4, 2022 for the product Prevantics Swab. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0571-2022
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
02-04-2022
03-02-2022
a) 160531 cases; b) 16123 cases
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Professional Disposables International, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed nationwide in the USA and Puerto Rico.
10-31-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# : a) 12000165, 12000166, 12000382, Exp Feb 2022; 12000228, 12000381, 12000383, 12000577, 12000578, 12000579, 12000661, 12000662, Exp Mar 2022; 12000659, 12000660, Exp Apr 2022; 12001060, 12001061, 12001062, 12001100 LE, 12001101 LE, Exp Jun 2022; 12001233, 12001234, 12001235, 12001236, Exp Jul 2022; 12001351, 12001394, 12001395, 12001396, 12001397, 12001398, 12001399, Exp Aug 2022; 12001632,12001633, 12001634, 12001635, 12001636, Exp Sep 2022; 12001637, 12001638, 12001639, 12001640, 12001641, 12001721, 12001791, Exp Oct 2022; 12001792, 12001793, 12001794, 12001962, Exp Nov 2022; 12002039, 12002040, 12100014, 12100015, 12100016, 12100017, 12100035, 12100036, 12100037, 12100074, 12100183, 12100184, Exp Jan 2023; 12100018, 12100185, 12100186, 12100192, 12100193, 12100194, 12100195, 12100241, 12100242, 12100243, 12100244, 12100245, 12100246, 12100247, 12100277, Exp Feb 2023; 12100312, 12100313, 12100347, 12100348, 12100349, Exp Mar 2023; 12100350, 12100351, 12100543, 12100638, Exp Apr 2023; 12100541, 12100542, 12100639, 12100732, 12100733, 12100753, 12100754, Exp May 2023; 12100755, 12100790, 12100791, 12100824, Exp Jun 2023; b) 12000194, 12000195, Exp Feb 2022; 12000500, 12000570, 12000594, 12000698, Exp Mar 2022; 12001058, 12001059, 12001069, 12001108 LE, 12001109 LE, 12001110 LE, Exp Jun 2022; 12001111 LE, 12001225, 12001226, 12001227, 12001228, 12001229, 12001230, Exp Jul 2022; 12001393, 12001522, Exp Aug 2022; 12001734, 12001735, 12001736, 12001737, Exp Oct 2022; 12001854, Exp Nov 2022; 12002033, 12002035, 12002045, 12002046, Exp Dec 2022; 12100019, 12100020, 12100021, 12100022, 12100096, 12100097, 12100098, 12100099, Exp Jan 2023; 12100196, 12100197, 12100251, 12100252, 12100253, 12100254, 12100255, 12100256, 12100257, 12100346, Exp Feb 2023; 12100363,12100364, 12100365, 12100366, Exp Mar 2023; 12100518, 12100519, 12100520, 12100521, Exp Apr 2023; 12100691, 12100693, Exp May 2023
Affected Packages Involved in this Recall
Recall Number: D-0570-2022
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
02-04-2022
03-02-2022
a) 9518 cases; b) 3347 cases
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Professional Disposables International, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed nationwide in the USA and Puerto Rico.
10-31-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# : a) 12000315, Exp Feb 2022; 12000700, Exp Mar 2022; 12001112 LE, Exp Jun 2022; 12001214, Exp Jul 2022; 12001362, 12001406, Exp Aug 2022; 12001628, Exp Sep 2022; 12001856, Exp Oct 2022; 12002103, Exp Dec 2022; 12002113, 12100024, Exp Jan 2023; 12100226, 12100227, Exp Feb 2023; 12100443, 12100503, Exp Mar 2023; 12100516, 12100517, Exp Apr 2023; 12100748, 12100756, Exp May 2023; b) 12001113 LE, Exp Jun 2022; 12001289, 12001240, Exp Jul 2022; 12002104, Exp Dec 2022; 12100025, Exp Jan 2023; 12100405, Exp Mar 2023; 12100674, Exp Apr 2023; 12100779, Exp May 2023
Affected Packages Involved in this Recall
Recall Number: D-0572-2022
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
02-04-2022
03-02-2022
a) 28201 cases; b) 7579 cases; c) 8882 cases
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Professional Disposables International, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed nationwide in the USA and Puerto Rico.
10-31-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration 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
