PDI Povidone-Iodine Prep Pad MEDIUM, 1 Prep Pad [2.0x2.5 in (5.1x6.4 cm)], Professional Disposabl...
FDA Drug Recall #D-0758-2021 — Class II — July 23, 2021
Recall Summary
| Recall Number | D-0758-2021 |
| 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 | 53588 cases |
Product Description
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,
Reason for Recall
SubPotent: Out of Specification
Distribution Pattern
Distributed Nationwide in the US
Lot / Code 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
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-0761-2021 | Class II | PDI Povidone-Iodine Swabstick (3's), 3 Swabstic... | 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.