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DURAMED RECALLING REMAINDER OF ANDAed PRODUCTS

Executive Summary

DURAMED RECALLING REMAINDER OF ANDAed PRODUCTS "not subject to prior recall" down to the wholesale level, the company announced May 15. Duramed said in a press release that "based largly on recent FDA regulatory interpretation, the products being recalled . . . were deemed not to have been manufactured in compliance with the ANDA." The latest recall effort involves 13 generic drug products: chlorpropamide 100 mg and 250 mg tablets; cyproheptadine 4 mg tabs; diazepam 2, 5 and 10 mg tabs; haloperidol 0.5, 1, 2, 5, 10 and 20 mg tabs; indomethacin 25 mg tabs; isoniazid 100 and 300 mg tabs; methyldopa 250 and 500 mg tabs; phentermine 30 mg capsules; prednisone 5, 10 and 20 mg tabs; propranolol HCl 10, 20, 40, 60, 80 and 90 mg tabs; propranolol HCl/hydrochlorothiazide 40/25 and 80/25 mg tabs; temazepam 15 and 30 mg caps; and tolazamide 100, 250 and 500 mg tabs. The recall affects all lots and package sizes of the 13 drugs sold under the Aligen, Best, Bioline, Dixon's, Duramed, Genetco, Geneva, Glenlawn, Goldline, Harber, Major, Mason, Mayrand, Kaiser, Moore, Mutual, Parmed, Purepac, Qualitest, Rugby, Schein or URL labels. The anti-nausea/anti-psychotic drug perchlorperazine is included in the wholesale-level recall. Duramed said it is "voluntarily withdrawing from the market" all lots of perchlorperazine maleate 5 and 10 mg tabs manufactured and distributed in 1990 "while it addresses unresolved issues." Reportedly, past production stocks of the drug have shown tablet coatings in excess of the amount approved in the ANDA. On Nov. 20, 1990, the company initiated a stop-shipment order for all its ANDA products that has continued into its sixth month while Duramed subjects its entire product line to an in-house audit and FDA review of the validation studies. Duramed cautioned in its 10-K that the outcome of the then incomplete audits and FDA's review of those audits "will, in all likelihood, result in the withdrawal of additional ANDAs and in additional product recalls." The company's annual report and 10-K, filed with the Securities and Exchange Commission on April 15 suggests that Duramed's problems are due to changes in FDA's regulatory interpretation. During the course of ongoing inspections and reviews by FDA, the company asserted in its annual report, "it became apparent to Duramed management that, in the company's view, many of the rules in the industry had changed and that the FDA was interpreting many old rules in new more stringent ways." The report states, "as a result Duramed found itself responding to questions on almost a daily basis and this pattern continues to the present." FDA inspections and reviews continued "at the date of this report," the company reported. Duramed was added to FDA's expanded generic drug manufacturers' compliance alert list in 1989; a September 1989 FDA inspection "found no evidence of fraud," the report notes. FDA "returned to Duramed throughout 1990" for a variety of reasons, including the company's recall of its conjugated estrogens products that began in December 1989 and eventually was expanded to include all estrogens products manufactured in 1990 ("The Pink Sheet" Feb. 18, T&G-14), "and other questions." At the time of the 10-K filing, Duramed said 13 product audits had yet to be completed: aminophylline; chlorpropamide; chlorzoxazone; cyproheptadine HCl; dipyridamole; diazepam; haloperidol; methyldopa; phentermine HCL; prednisone; temazepan; isonioazid; and tolazamide. All but aminophylline, chlorzoxazone and dipyridamole are part of the recall announced May 15. Audits had been completed and were under review as of April 15 at FDA for: prochlorperazine; trifluoperazine HCL; and propranolol HCL,the document reports. The results of the internal audit of trifluoperazine remain under review at FDA, the agency said. Although the company is including propranolol 80 mg in the latest recall announcement, Duramed said in the 10-K that it has already withdrawn the 80 mg dose of propranolol "as a result of its audit." Recalls have been initiated on two other products reviewed by the company based upon audit results, the report states. The audit of clonidine HCl "resulted in the decision to voluntarily withdraw the company's ANDA," the 10-K states. The audit of hydroxyzine pamoate "resulted in a recommendation that a new biostudy be performed and submitted to the FDA as a supplement to the ANDA." Clonidine, hydroxyzine and trifluoperazine were three of five products Duramed announced it was recalling on Jan. 14 of this year ("The Pink Sheet" Jan. 21, T&G-11). To date, only the steroid product methylprednisolone has been returned to the market. Prochlorperazine was the fifth product in the January recall.
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