Multi-event July 2021 FDA Recall Pvp Iodine Prep Pad by Professional Disposables International, Inc
This Multi-event Class II drug recall was voluntarily initiated by Professional Disposables International, Inc on July 23, 2021 for the product Pvp Iodine Prep Pad. The FDA reported the reason for recall as subpotent. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0762-2021
SubPotent: Out of Specification
07-23-2021
09-01-2021
5,477 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.
Distributed Nationwide in the US
05-31-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
PDI Povidone-Iodine Cleansing Scrub Swabstick (1's), 1 Swabstick, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S48050, NDC 10819-3891-2, UPC (01)00310819000192.
Batch or Lot Expiration Information
Lot# 's 11901081, EXP 2023-04-04; 11901340, EXP 2023-04-05; 11901593, EXP 2023-04-06; 11901594, EXP 2023-04-07; 12000784, EXP 2023-04-08; 12000992, EXP 2023-04-09; 12001492, EXP 2023-04-10; 12001699, EXP 2023-04-11; 12100121, EXP 2023-04-12; 12100453, EXP 2023-04-13
Recall Number: D-0763-2021
SubPotent: Out of Specification
07-23-2021
09-01-2021
3,113 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.
Distributed Nationwide in the US
05-31-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
PDI Povidone-Iodide Cleansing Scrub Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376, Reorder No S82125, NDC 10819-3891-3, UPC (01)00310819000208.
Batch or Lot Expiration Information
Lot# 's 11901080, EXP 2023-04-14; 11901339, EXP 2023-04-15; 11901755, EXP 2023-04-16; 12000016, EXP 2023-04-17; 12000397, EXP 2023-04-18; 12000987, EXP 2023-04-19; 12001578, EXP 2023-04-20; 12001814, EXP 2023-04-21
Recall Number: D-0764-2021
SubPotent: Out of Specification
07-23-2021
09-01-2021
11,039 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.
Distributed Nationwide in the US
05-31-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick, (1's), Step 1, packaged as a) Step 1 Scrub, 1 Swabstick, NDC 10819-3891-1, b) Step 2 Prep, 1 Swabstick, NDC 10819-3890-1, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S23125, UPC (01)00318019000161
Batch or Lot Expiration Information
Lot# SKU S23125
Lot# 's 11900971, 11901517, 11901756, 12000199, 12000286, 12000459, 12000686, 12000751, 12001009, 12001316, 12001795, 12001809, 12001862, 12001863, 12002140, 12002141, 12100392 and 12100393
Recall Number: D-0759-2021
SubPotent: Out of Specification
07-23-2021
09-01-2021
1982 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.
Distributed Nationwide in the US
05-31-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
PDI Povidone-Iodine Prep Pad Large, 1 Prep Pad, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 USA Reorder No C12400 NDC 10819-3883-3, UPC (01)00310819000154
Batch or Lot Expiration Information
Lot# 's 11801215, EXP 2021-08-22; 11801504, EXP 2021-11-06; 11801717,EXP 2021-12-07; 11900421, EXP 2022-04-04; 11901076, EXP 2022-08-29; 11901571, EXP 2022-11-19; 12000388, EXP 2023-03-13; 12001533 EXP 2023-07-28; 12100459 EXP 2024-03-31
Recall Number: D-0761-2021
SubPotent: Out of Specification
07-23-2021
09-01-2021
51,926 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.
Distributed Nationwide in the US
05-31-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
PDI Povidone-Iodine Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S41125 NDC 10819-3885-2, UPC (01)00310819000185
Batch or Lot Expiration Information
Lot# 's 11900761, EXP 2022-11-03; 11900917, EXP 2022-11-04; 11900918, EXP 2022-11-05; 11901008, EXP 2022-11-06; 11901009, EXP 2022-11-07; 11901124, EXP 2022-11-08; 11901125, EXP 2022-11-09; 11901126, EXP 2022-11-10;11901127, EXP 2022-11-11; 11901179, EXP 2022-11-12; 11901180, EXP 2022-11-13; 11901247, EXP 2022-11-14; 11901248, EXP 2022-11-15; 11901388, EXP 2022-11-16;11901389, EXP 2022-11-17; 11901390, EXP 2022-11-18; 11901419, EXP 2022-11-19; 11901420, EXP 2022-11-20; 11901480, EXP 2022-11-21; 11901558, EXP 2022-11-22;11901590, EXP 2022-11-23; 11901591, EXP 2022-11-24; 11901592, EXP 2022-11-25; 11901691, EXP 2022-11-26; 11901692, EXP 2022-11-27; 12000054, EXP 2022-11-28; 12000055, EXP 2022-11-29; 12000116, EXP 2022-11-30; 12000117, EXP 2022-12-01; 12000172, EXP 2022-12-02; 12000173, EXP 2022-12-03; 12000189, EXP 2022-12-04; 12000190, EXP 2022-12-05; 12000287, EXP 2022-12-06; 12000288, EXP 2022-12-07; 12000346, EXP 2022-12-08; 12000347, EXP 2022-12-09; 12000452, EXP 2022-12-10; 12000453, EXP 2022-12-11; 12000454, EXP 2022-12-12; 12000455, EXP 2022-12-13; 12000679, EXP 2022-12-14; 12000680, EXP 2022-12-15; 12000681, EXP 2022-12-16; 12000682, EXP 2022-12-17; 12000881, EXP 2022-12-18; 12000882, EXP 2022-12-19; 12000883, EXP 2022-12-20; 12000884, EXP 2022-12-21; 12001003, EXP 2022-12-22; 12001004, EXP 2022-12-23; 12001005, EXP 2022-12-24; 12001006, EXP 2022-12-25; 12001150, EXP 2022-12-26; 12001151, EXP 2022-12-27; 12001184, EXP 2022-12-28; 12001283, EXP 2022-12-29; 12001284, EXP 2022-12-30; 12001285, EXP 2022-12-31; 12001510, EXP 2023-01-01; 12001513, EXP 2023-01-02; 12001514, EXP 2023-01-03; 12001515, EXP 2023-01-04; 12001598, EXP 2023-01-05; 12001599, EXP 2023-01-06; 12001600, EXP 2023-01-07; 12001786, EXP 2023-01-08; 12001789, EXP 2023-01-09; 12001790, EXP 2023-01-10; 12001843, EXP 2023-01-11; 12001844, EXP 2023-01-12; 12001981, EXP 2023-01-13; 12001982, EXP 2023-01-14; 12002006, EXP 2023-01-15; 12002007, EXP 2023-01-16; 12002148, EXP 2023-01-17; 12002149, EXP 2023-01-18; 12100119, EXP 2023-01-19; 12100120, EXP 2023-01-20; 12100237, EXP 2023-01-21; 12100238, EXP 2023-01-22; 12100239, EXP 2023-01-23; 12100240, EXP 2023-01-24; 12100456, EXP 2023-01-25; 12100457, EXP 2023-01-26; 12100537, EXP 2023-01-27
Recall Number: D-0758-2021
SubPotent: Out of Specification
07-23-2021
09-01-2021
53588 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.
Distributed Nationwide in the US
05-31-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
PDI Povidone-Iodine Prep Pad MEDIUM, 1 Prep Pad [2.0x2.5 in (5.1x6.4 cm)], Professional Disposables International Inc., Orangeburg, NY 10962-1376 Reorder No. B40600; UPC (01)00310819000147, NDC 10819-3883-1,
Batch or Lot Expiration Information
Lot# 's EXP date 11800977, 2021-07-31; 11800978 2021-08-02; 11800979 2021-08-04; 11801123 2021-08-06; 11801124 2021-08-09; 11801125 2021-08-15; 11801126 2021-08-16; 11801228 2021-08-28; 11801230 2021-09-11; 11801231 2021-09-13; 11801232 2021-09-18; 11801234 2021-10-25; 11801417 2021-10-28; 11801418 2021-11-01; 11801419 2021-11-07; 11801420 2021-11-15; 11801421 2021-11-20; 11801709 2021-11-29; 11801710 2021-12-04; 11900195 2022-02-19; 11900196 2022-02-21; 11900197 2022-02-25; 11900370 2022-04-01; 11900372 2022-04-03; 11900371 2022-04-05; 11900647 2022-05-04; 11900623 2022-05-21; 11900624 2022-05-24; 11900646 2022-05-29; 11900967 2022-08-13; 11900968 2022-08-26; 11900969 2022-08-28; 11901043 2022-09-11; 11901044 2022-09-18; 11901318 2022-10-03; 11901330 2022-10-08; 11901331 2022-10-16; 11901446 2022-10-28; 11901447 2022-11-19; 11901448 2022-12-19; 11901739 2023-01-02; 11901752 2023-01-09; 12000045 2023-01-14; 12000048 2023-01-18; 12000046 2023-01-21; 12000047 2023-01-24; 12000333 2023-01-25; 12000675 2023-02-16; 12000334 2023-02-27; 12000335 2023-02-27; 12000336 2023-02-28; 12000676 2023-03-16; 12000815 2023-03-29; 12000816 2023-05-05; 12000914 2023-05-13; 12000915 2023-05-18; 12000951 2023-05-22; 12000950 2023-06-01; 12001366 2023-08-12; 12001367 2023-08-14; 12001368 2023-08-17; 12001370 2023-08-21; 12001369 2023-08-21; 12001371 2023-08-25; 12001372 2023-09-30; 12001818 2023-09-30; 12001820 2023-09-30; 12001819 2023-11-30; 12001821 2023-11-30; 12001822 2023-11-30; 12001972 2023-12-31; 12001973 2023-12-31; 12001974 2023-12-31; 12001975 2023-12-31; 12001976 2023-12-31; 12001977 2023-12-31; 12001978 2023-12-31; 12100080 2023-12-31; 12100081 2023-12-31; 12100082 2024-02-29; 12100084 2024-02-29; 12100447 2024-03-31; 11800978, 11800979, 11801123, 11801124, 11801125, 11801126, 11801228, 11801230, 11801231, 11801232, 11801234, 11801417,11801418, 11801419, 11801420, 11801421, 11801709, 11801710, 11900195, 11900196, 11900197, 11900370, 11900371, 11900372, 11900623, 11900624, 11900646, 11900647, 11900967, 11900968, 11900969, 11901043, 11901044, 11901318, 11901330, 11901331, 11901446, 11901447, 11901448, 11901739, 11901752, 12000045, 12000046, 12000047, 12000048, 12000333, 12000334, 12000335, 12000336, 12000675, 12000676, 12000815, 12000816, 12000914, 12000915, 12000950, 12000951, 12001366, 12001367, 12001368, 12001369, 12001370, 12001371, 12001372, 12001818, 12001819, 12001820, 12001821, 12001822, 12001972, 12001973, 12001974, 12001975, 12001976, 12001977, 12001978, 12100080, 12100081, 12100082, 12100084 and 12100447
Recall Number: D-0760-2021
SubPotent: Out of Specification
07-23-2021
09-01-2021
41,105 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.
Distributed Nationwide in the US
05-31-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
PDI Povidine Iodine Swabstick (1's), 1 swabstick, Professional Disposable International, Inc. Orangeburg, NY 10962 -1376 Reorder No S41350 NDC 10819-3885-1, UPC (01)00310819000178.
Batch or Lot Expiration Information
Lot# 's 11900790, EXP 2021-07-25; 11900919, EXP 2021-07-28; 11900920, EXP 2021-08-12; 11900921, EXP 2021-08-15; 11901106, EXP 2021-08-27; 11901107, EXP 2021-08-30; 11901128, EXP 2021-09-05; 11901129, EXP 2021-09-12;11901249, EXP 2021-09-25; 11901250, EXP 2021-10-17; 11901391, EXP 2021-10-19; 11901392, EXP 2021-10-22; 11901438, EXP 2021-10-24; 11901439, EXP 2021-10-08; 11901457, EXP 2021-11-07; 11901541, EXP 2021-11-18; 11901603, EXP 2021-11-19; 11901604, EXP 2021-12-19; 11901669, EXP 2021-12-19; 11901670, EXP 2021-11-16; 11901702, EXP 2021-12-02; 11901703, EXP 2021-12-14; 12000082, EXP 2021-12-19; 12000083, EXP 2022-01-24; 12000118, EXP 2022-01-03; 12000119, EXP 2022-01-30; 12000249, EXP 2022-01-10; 12000250, EXP 2022-01-10; 12000348, EXP 2022-02-13; 12000349, EXP 2022-02-28; 12000398, EXP 2022-02-05; 12000456, EXP 2022-03-12; 12000457, EXP 2022-03-12; 12000683, EXP 2022-03-23; 12000684, EXP 2022-03-30; 12000685, EXP 2022-04-04; 12000922, EXP 2022-05-15; 12000923, EXP 2022-05-19; 12000927, EXP 2022-05-21; 12000989, EXP 2022-06-15; 12000990, EXP 2022-06-05; 12000991, EXP 2022-06-10; 12001154, EXP 2022-06-26; 12001155, EXP 2022-06-24; 12001231, EXP 2022-07-26; 12001232, EXP 2022-07-21; 12001243, EXP 2022-07-03; 12001244, EXP 2022-07-04; 12001537, EXP 2022-08-31; 12001538, EXP 2022-08-31; 12001539, EXP 2022-08-31; 12001540, EXP 2022-09-30; 12001666, EXP 2022-09-30; 12001667, EXP 2022-09-30; 12001668, EXP 2022-09-30; 12001669, EXP 2022-09-30; 12001841, EXP 2022-10-31; 12001842, EXP 2022-10-31; 12001959, EXP 2022-10-31; 12002072, EXP 2022-11-30; 12100123, EXP 2023-02-28; 12100124, EXP 2023-02-28; 12100454, EXP 2023-03-31; 12100455, EXP 2023-03-31; 12100590, EXP 2023-04-30; 12100591, EXP 2023-04-30
