October 5, 1999
PRE-PENÆ Skin Test Antigen Recalled for
Spokane, WA (SafetyAlerts) -- The FDA today issued
notice that Hollister-Stier Laboratories LLC, of Spokane, Washington is continuing its
recall of PRE-PENÆ Skin Test Antigen Rx in single dose ampuls - a Rx used in assessing a
patient's allergy status to penicillin. The recall is being conducted due to subpotemcy
indications during routine 30 month stability testing.
According to the FDA the product was distributed
to nationwide(U.S.) and International markets. Hollister-Stier initiated the recall
by letters sent on September 3 and 8, 1999. The FDA's description of the product is
"PRE-PENÆ Skin Test Antigen,
(benzylpenicilloyl polylysine injection, USP), in single dose ampuls (5 per carton), Rx
used in assessing a patient's allergy status to penicillin.NDC #0091-1640-05."
The product identification codes are listed as:
Lot #33911, 33912, 33913 EXP 10/99. According to the FDA 500 units of lot 33911,
4,716 units of lot 33912 and 200 units of lot 33913 were distributed.
This recall has been certified as a Class II recall by the FDA.
Questions concerning this recall may be directed
to the Food and Drug Administration at 1-800-INFO-FDA. The reference number is: Recall
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