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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
March 31, 1999

PRODUCT
a) Povidone-Iodine Solution, USP 10%, packaged in 3/4 fluid ounce (22mL) packets, distributed under one brand name - Professional Disposables, Inc., labeled as an antiseptic and germicide; b) Povidone-Iodine Prep Pad, sold in small and medium sizes, saturated with a 10% povidone-iodine solution, labeled as an antiseptic and germicide, distributed under the following brand names: Professional Disposables, Inc., ABCO, Allegiance, Bergen Brunswig, Medline, and Total Resources. Recall #D-154/155-9.

CODE
Lot numbers:  a) 7006741 EXP 12/00, Item #L57725.
b) Brand          Lot No.          Item No.         EXP
   PDI             9700009438,      B40600,       12/2000
                  9700009695,      B40600,       12/2000
                  9700009939,      B40600,       12/2000
                  9700010027,      B40600,       12/2000
                  9800000781       B40600,       12/2000
                  9800000533       B40600        01/01
                  9800001356       B40600        01/01
                  9800001493       B40600        01/01
                  9800002497       B40600        01/01
                  9800003002       B40600        01/01
                  9800000161       B40673        12/2000
                  9800002312       B40701        01/01)
   ABCO           9700010542       B14200        12/00)
   Allegiance     9700009572       B87500        12/00
                  9700010571       B87500        12/00
                  9800002492       B87500        01/01
Bergen Brunswig   9800002175      B60600         01/01
Medline           9800000615       B64200        01/00)
                  9800002320       B64204        01/01)
Total Resources   9800000069      B08589         12/00).

MANUFACTURER
Nice-Pak Products, Inc., Orangeburg, New York.

RECALLED BY
Manufacturer, by letters on February 2 and 19, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide, Canada, Ireland, Portugal.

QUANTITY
a) 352 cases (250 packets per case); b) 7,125 cases (1,000 prep pads per case) were distributed.

REASON
Microbial contamination with Pseudomonas putida, Salmonella spp. Poly D, and Aeromonas sobria.

 

The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.