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This article was originally published in The Tan Sheet

Executive Summary

BLOCK DRUG WILL REVISE BC HEADACHE POWDER TRPs by the end of May, according to the agency's Nashville district office. In response to a Feb. 9 warning letter issued by Nashville District Director Raymond Hedblad to the firm, Block Drug requested 12 weeks beginning Feb. 26 to assure that its BC Fast Pain Relief Powder line incorporates a satisfactory tamper-resistant packaging (TRP) feature. FDA granted Block's request at the end of February. In the warning letter, the agency cited the firm for not assuring that its products "possess a minimum of one" TRP feature. FDA observed that BC powders in packs of two, six, 24 and 50 had film wrappers with overlapping end flaps that could be "opened and resealed without visible evidence of entry." A May 1988 FDA compliance policy guide on TRP requirements stipulates that the "sealing of a film wrapper with overlapping end flaps is acceptable only if the ends cannot be opened and resealed without leaving visible evidence of tampering," FDA pointed out. Specifically, the agency told Block Drug that the "tear band imprinted with the logo 'BC' which surrounds the entire package is not capable of meeting the tamper-resistant packaging requirements" because the end flaps are still susceptible to tampering. Block stated that it is "fully cooperating" with FDA in bringing BC powder packaging into compliance with the 1988 TRP policy guide. An FDA official said that the Nashville district already has received a submission from Block indicating the design of the new tamper-resistant packaging. Block said it will continue to market the headache powder until new packaging is implemented. The warning letter to Block came less than two months after Winston-Salem, N.C.-based Goody Manufacturing voluntarily recalled its Goody's Headache Powder on Dec. 23, 1992 because of what was thought to be a tampering incident: a Tennessee man died of cyanide poisoning after ingesting the product. However, subsequent tests indicated that no other packages of the headache powder were contaminated. Goody replaced its previous cellophane wrapper with shrink-wrapped beaded plastic and returned the product to the market on Jan. 28. Nashville district officials indicated that the warning letter to Block was related to the Goody incident because the tampering scare called attention to how locally available headache powders were packaged. Block Drug and Goody are the only manufacturers marketing headache powder in the Nashville region. Block said it markets the powder primarily in the southern states.

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