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Professional Disposables International, Inc. FDA Recalls
10 recalls on file across drugs, 0 of them Class I and 0 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swab, 3.15% w/v and 70% v/v, packaged as a) One Swab, 0.034 fClass IIFeb 4, 2022cGMP deviations: uncertainty of the adequacy of the validati |
| Prevantics (chlorhexidine gluconate and isopropyl alcohol) Maxi Swabstick, 3.15% w/v and 70% v/v, packaged as a) One MaxClass IIFeb 4, 2022cGMP deviations: uncertainty of the adequacy of the validati |
| Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swabstick, 3.15% w/v and 70% v/v, packaged as a) One SwabsticClass IIFeb 4, 2022cGMP deviations: uncertainty of the adequacy of the validati |
| PDI Povidone-Iodine Prep Pad MEDIUM, 1 Prep Pad [2.0x2.5 in (5.1x6.4 cm)], Professional Disposables International Inc., Class IIJul 23, 2021SubPotent: Out of Specification |
| PDI Povidine Iodine Swabstick (1's), 1 swabstick, Professional Disposable International, Inc. Orangeburg, NY 10962 -1376Class IIJul 23, 2021SubPotent: Out of Specification |
| PDI Povidone-Iodine Prep Pad Large, 1 Prep Pad, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Class IIJul 23, 2021SubPotent: Out of Specification |
| PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick, (1's), Step 1, packaged as a) Step 1 Scrub, 1 Swabstick, NDC 10Class IIJul 23, 2021SubPotent: Out of Specification |
| PDI Povidone-Iodide Cleansing Scrub Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., OrangebuClass IIJul 23, 2021SubPotent: Out of Specification |
| PDI Povidone-Iodine Cleansing Scrub Swabstick (1's), 1 Swabstick, Professional Disposable International, Inc., OrangeburClass IIJul 23, 2021SubPotent: Out of Specification |
| PDI Povidone-Iodine Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -13Class IIJul 23, 2021SubPotent: Out of Specification |