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Executive Summary

BOLAR RECALLING ANOTHER SEVEN PRODUCTS due to the company's determination that the drugs "were not manufactured in accordance with FDA approvals and/or that the company's records do not accurately reflect the processes by which these drugs or batches thereof were manufactured and/or because their bioequivalence cannot be assured." The recall was announced in a company release dated Aug. 27. The seven affected products are propranolol hydrochloride tablets, procainamide hydrochloride tablets, tolazamide tablets, carisoprodol tablets, methocarbamol tablets, metoclopramide tablets, and timolol maleate tablets. The action follows an earlier recall of methylclothiaside with reserpine, ergoloid mesylates, pentaerythritol tetranitrate tablets, and meclofenamate sodium -- the first three for manufacturing problems and the fourth for suspected fraud ("The Pink Sheet" July 30, T&G-11). The 11 products combined accounted for 43% of Bolar's pre-tax income in 1989, the company said. In addition, Bolar said its is withdrawing from the market another 38 products, including 14 that it also announced in July would be no longer manufactured due to "economic reasons." This leaves 12 products either in stock on the market or still being sold by Bolar. "Although the preliminary audits have not revealed a problem with any particular lot or the underlying product applications of the 38 additional products, Bolar's management recognizes its obligation to assure...that questions which may be asked about its products have been anticipated and fully resolved," the company explained. "Consequently, Bolar is withdrawing existing stocks on the market of these products pending completion of comprehensive audits satisfactory to FDA." Audits will not be carried out on the 14 products no longer manufactured. The other 24 products accounted for 67% of net sales in 1989 and 34% of income before taxes and extraordinary items, "giving effect to previously announced recalls and reserves," the company said. The 12 remaining products include amantadine hydrochloride capsules, bethanechol chloride tabs, carisoprodol tablets, chlorthalidone tablets, cyproheptadine hydrochloride tablets, and isoniasid tabs. The others are quinine sulfate, sulfasalazine tablets, trihexyphenidyl hydrochloride tablets, nitroglycerine transdermal patches, L-5 hydrohytryphan, and primidone tablets, a veterinary product.



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