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.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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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