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Class II: temporary or reversible health riskTerminated

Professional Disposables International PDI Povidone-Iodine Swabstick Recall

PDI Povidone-Iodine Swabstick (3's), 3 Swabsticks, Professional Disposable Internationa…

Professional Disposables International, Inc · Woodcliff Lake, NJ

Risk level
Class II
Reported by FDA
Sep 1, 2021
Recall ID
D-0761-2021
Check your lot numberHow we source this data

Summary

Professional Disposables International recalled PDI Povidone-Iodine Swabstick starting Jul 23, 2021. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0761-2021 on Sep 1, 2021. Reason: SubPotent: Out of Specification. Status: Terminated.

Why it was recalled

SubPotent: Out of Specification

Product description

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

Lot numbers, UPCs & expiration codes

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;

Where it was sold

Distributed Nationwide in the US

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0761-2021
Classification
Class II
Status
Terminated
Recall initiated
Jul 23, 2021
FDA report date
Sep 1, 2021
Quantity
51,926 cases
Recall type
Voluntary: Firm initiated
Recalling firm
Professional Disposables International, Inc

Original FDA data

Every field from FDA enforcement report D-0761-2021, exactly as published.

Show all FDA fields
City
Woodcliff Lake
State
NJ
Status
Terminated
Country
United States
Event ID
88326
Address
400 Chestnut Ridge Rd
Code 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;
Postal code
07677-7604
Report date
Sep 1, 2021
Product type
Drugs
Recall number
D-0761-2021
Classification
Class II
Recalling firm
Professional Disposables International, Inc
Product quantity
51,926 cases
Termination date
May 31, 2023
Reason for recall
SubPotent: Out of Specification
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
Distributed Nationwide in the US
Recall initiation date
Jul 23, 2021
Initial firm notification
Letter
Center classification date
Aug 20, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0761-2021, published Sep 1, 2021. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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