The Recall Desk
ModerateFDA (Drugs)·D-0762-2021·Announced 2021-09-01

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
Category
Drug — Topical antiseptic / Cleansing product
Hazard
  • subpotency
  • out-of-specification

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.

Related recalls

Same category