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Executive Summary

BIOCRAFT CLASS I RECALL: CHLOROQUINE ANTIMALARIAL MISLABELING led to the appearance of an animal dosage form of furosemide in approximately 24 bottles of Goldline distributed chloroquine. Biocraft is recalling approximately 1,400 bottles (100 tabs each) of Goldline brand chloroquine phosphate 250 mg tablets, lot number 14311, distributed between August and November. The recall to the retail level began in mid-November when it was discovered that bottles of an animal formulation of the diuretic furosemide had been mistakenly labeled as the antimalarial chloroquine phosphate. Both drugs are bottled and labeled in the same Biocraft facility. Biocraft bases its estimate that 24 bottles of the mislabeled product were distributed on discrepancies in manufacturing yield logs. As of Dec. 1, nine of the 24 bottles bottles had been recovered, Biocraft President Harold Snyder said. According to a Dec. 1 FDA press release announcing the recall, the error was discovered by a pharmacist, who found oval off-white tablets embossed with "BL" on one side and "54" on the other side in a chloroquine labeled bottle. Chloroquine tablets are round and white with "BL" on one side and "38" on the other. Biocraft notes that the furosemide tablets are low potency. FDA warns, however, that "patients taking large doses of diuretic can suffer from electrolyte depletion, which might lead to irregular heartbeat, weakness or low blood pressure." In addition, people taking the mislabeled product "would not be protected against or treated for malaria," the agency noted. FDA estimates that about 1,000 bottles of the product may still be in drug stores or dispensed to patients. Chloroquine labeled bottles containing furosemide have been found in California, Utah, Arizona and Oregon. "No injuries or deaths have been reported as a result of the label mix-up," the agency said. The recall announcement comes on top of a recent regulatory letter to Biocraft on its cephalexin monohydrate production. That regulatory letter, issued by FDA on Oct. 30, was cited at House hearings this month before Rep. Dingell's (D-Mich.) Oversight Subcommittee as a recent example of GMP problems turned up in the generic industry ("The Pink Sheet" Nov. 27, p. 4). Biocraft had ridden through the first rounds of the generic investigations without much mention.

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