March 3, 2001 - Voluntary Market Withdrawal - Adverse Drug Reaction

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Re: RAPLON (rapacuronium bromide) for Injection

ALL BATCHES

NDC 0052-0490-15 (100 mg)

NDC 0052-0495-16 (200 mg)

NDC 0052-0490-86 (100 mg sample)

In light of the recent safety issues raised, regarding RAPLON and its possible association with the occurrence of bronchospasm, we are voluntarily withdrawing the product. We feel a strong responsibility to the clinicians that not only use our products, but also entrust the lives of their patients on the reliability of these products. Our primary concern and goal in this endeavor is to ensure the safety of each patient. The Food and Drug Administration (FDA) was notified immediately of this decision and the planned market withdrawal of all unused product.

The RAPLON package insert lists bronchospasm as an adverse event which occurred in 3.2% of patients in premarketing clinical trials. We have now received reports of several serious adverse bronchospasm events including a few unexplained fatalities. In each of these cases the cause is unknown, as there were multiple drugs administered and other conditions present. From our surveillance of postmarketing spontaneous reporting, it appears that the incidence is within labeling, however, the severity of these events, up to and including mortality that has been reported postmarketing, was not seen in clinical trials. These reports are made voluntarily from a population of unknown size and the exact frequency can not be determined.

Please examine your stock immediately to determine if you have any RAPLON in your inventory. If so, discontinue using the material and have your hospital pharmacy or wholesaler promptly return via parcel post to our West Orange facility: Attn: RETURN MARKET WITHDRAWAL.

If you or a loved one has suffered an injury as a result of taking any drug or supplement, call The Gunn Law Group now at (813) 228-7070 or CLICK HERE TO SUBMIT A SIMPLE CASE FORM. The initial consultation is free of charge, and if we agree to review your case, we will work on a contingent fee basis, which means we get paid for our services only if there is a monetary award or recovery of funds. Don't delay! You may have a valid claim and be entitled to compensation for your injuries, but a lawsuit must be filed before the statute of limitations expires.

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