PDI Povidone-Iodine Cleansing Scrub Swabstick Recalled for Subpotency
Professional Disposables International is recalling PDI Povidone-Iodine Cleansing Scrub Swabsticks distributed nationwide because the product is subpotent—meaning it contains less active ingredient than specified.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for a drug product with a manufacturing defect (subpotency). No hospitalizations or reported illnesses are stated in the source. The defect is a quality/potency issue rather than a contamination or safety hazard with direct injury risk.
Plain-English summary
Professional Disposables International, Inc. is recalling PDI Povidone-Iodine Cleansing Scrub Swabsticks (1's) nationwide. The product is classified as subpotent, meaning it fails to meet the specified potency standard for povidone-iodine content.
Approximately 5,477 cases of the affected product have been distributed. The affected lot numbers are 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), and 12100453 (EXP 2023-04-13).
Healthcare facilities and users of these swabsticks should stop using affected lots and contact Professional Disposables International, Inc. for replacement or further instructions.
The recalled product
- 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.
- Manufacturer
- Professional Disposables International, Inc
- Affected units
- 5,477
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Professional Disposables International, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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