PDI Povidone-Iodine Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., O...
FDA Drug Recall #D-0761-2021 — Class II — July 23, 2021
Recall Summary
| Recall Number | D-0761-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 23, 2021 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Professional Disposables International, Inc |
| Location | Woodcliff Lake, NJ |
| Product Type | Drugs |
| Quantity | 51,926 cases |
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
Reason for Recall
SubPotent: Out of Specification
Distribution Pattern
Distributed Nationwide in the US
Lot / 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;
Other Recalls from Professional Disposables Internationa...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0764-2021 | Class II | PDI Duo-Swab Povidone-Iodine Cleansing Scrub Sw... | Jul 23, 2021 |
| D-0762-2021 | Class II | PDI Povidone-Iodine Cleansing Scrub Swabstick (... | Jul 23, 2021 |
| D-0759-2021 | Class II | PDI Povidone-Iodine Prep Pad Large, 1 Prep Pad,... | Jul 23, 2021 |
| D-0758-2021 | Class II | PDI Povidone-Iodine Prep Pad MEDIUM, 1 Prep Pad... | Jul 23, 2021 |
| D-0763-2021 | Class II | PDI Povidone-Iodide Cleansing Scrub Swabstick (... | Jul 23, 2021 |
Frequently Asked Questions
Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.