November 3, 2000Voluntary Recall of Allergenic
Extract -Tuna, for Scratch, Prick or Puncture Testing
WA (SafetyAlerts) - The Food and
Drug Administration (FDA) said today that Hollister-Stier Laboratories LLC is conducting a
voluntary recall one lot of Allergenic Extract -Tuna because the product was recalled due
to lack of assurance of sterility.
While the required sterility tests
results were acceptable following manufacture of this lot, a subsequent review of the test
results and an associated internal investigation resulted in questions regarding the
conclusions made at the time of release.
This is the first public notice
issued by FDA.
Allergenic Extract -Tuna, for Scratch, Prick or Puncture Testing
DATE RECALL INITIATED:
October 3, 2000
LOT NUMBER / EXPIRATION DATE:
Hollister-Stier Laboratories LLC
3525 North Regal Street
Spokane, WA 99220-3145
QUANTITY and DISTRIBUTION:
Not released in FDA report.
Questions concerning this recall may be directed
to the FDA at 1-888-INFO-FDA.
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