NON-STERILE WIPES FOUND TO BE CONTAMINATED BY FDA SAMPLING AND ANALYSES
COMMENT
FDA sampling and analyses of non-sterile alcohol prep pads were found to be contaminated with Bacillus cereus. Based on USP<61> and <62> wherein “specified” in-house microorganisms are considered objectionable, over 285 million packets are being recalled.
Non-Sterile Alcohol Prep Pads/Swabs, saturated with 70% v/v
Isopropyl Alcohol, distributed under the following labels, sizes and codes: a)
PDI Alcohol Prep Pad, MEDIUM, For Professional and Hospital Use, 200 Packets
(pads) per box, NDC 10819-3912-1, 10 x 200s, 15 x 200s, 3000 pads; a-c) PDI
Item #s B-33901, B33905, B33973, B68870, C29600; b) PDI Alcohol Pads, medium,
100 Individually Foiled Wrapped Pads per box, NDC 10819-3912-3, UPC 0 74887
10050 4; c) PDI Alcohol Prep Pad, LARGE, For Professional and Hospital Use, 100
Packets (pads) per box, NDC 10819-3912-2; d) McKesson Medi-Pak Alcohol Prep
Pads – MEDIUM, Non-Sterile, Single Use, Latex-Free, 200 Packets (pads) per box,
NDC 68599-5805-1, McKesson Medi-Pak Item #s B-85637, Reorder No. 58-104; e)
McKesson Medi-Pak Alcohol Prep Pads – LARGE, Non-Sterile, Single Use,
Latex-Free, 100 Packets (pads) per box, NDC 68599-5805-2, McKesson Medi-Pak
Item # C42500, Reorder No. 58-304; f) Medichoice Alcohol Prep Pads, MEDIUM,
Non-Sterile, Single Use, Latex-Free, 200 Packets (pads) per box, NDC
65517-00021, Medichoice Item #s B91437 and C73400; Reorder # 4725APP101, g)
Medichoice Alcohol Prep Pads, LARGE, Non-Sterile, Single Use, Latex-Free, 100
Packets (pads) per box, NDC 65571-00021, Medichoice Item # C73400, Reorder #
4725APP103; h) ProAdvantage Non-Sterile Alcohol Prep Pads, Medium, For
Professional and Hospital Use, 200 Packets (pads) per box, NDC 43128-3910-2, ProAdvantage
Item #s B34700; i) ProAdvantage Non-Sterile Alcohol Prep Pads, Large, For
Professional and Hospital Use,100 packets (pads) per box, NDC 43128-3910-1,
ProAdvantage Item #C36100; j) Duane Reade Alcohol Prep Swab,100 Swabs per box,
UPC 6 39194 00694 1, Duane Reade Item # B81071; k) ShopRite Alcohol Prep
Swabs,100 Swabs per box, UPC 0 41190 20995 4, ShopRite Item # B32071. Recall #
D-1579-2011
CODE
All lots
RECALLING FIRM/MANUFACTURER
Professional Disposables International, Inc., Orangeburg,
NY, by letters dated September 16, 2011. Firm initiated recall is ongoing.
REASON
Microbial Contamination of Non-Sterile Products: The
non-sterile alcohol prep pads/swabs were found to be contaminated with Bacillus
cereus based on FDA sampling and analysis.
VOLUME OF PRODUCT IN COMMERCE
285,478,600 Packets (Pads)
DISTRIBUTION
Nationwide
FDA Enforcement Report October 5, 2011
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