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Safety Alerts
October 5, 1999

PRE-PENÆ Skin Test Antigen Recalled for Subpotency

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 as follows:

"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 #D-424-9.

Safety Alerts compiles comprehensive safety recall information for the United States. SafeMail is a free email service to warn consumers of faulty products and contaminated foods. For complete information regarding current recalls, past recalls and timely product warning notification visit: www.safetyalerts.com.

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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.