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1/25/2001

FDA Strengthens Warning About Recalled Phyne Injectables

Kate Traynor

The Food and Drug Administration (FDA) has issued a new urgent recall notice affecting injectable products marketed by Scottsdale, Ariz.-based Phyne Pharmaceuticals Inc.

FDA’s notice follows Phyne’s Dec. 14 recall of a large number of injectable drugs of questionable potency and sterility. The recalled products were marketed by Phyne but manufactured by Rathdrum, Idaho-based Amram Inc., and may bear labels from one or both companies.

FDA expressed dissatisfaction with Phyne’s efforts to remove these potentially dangerous products from the market. According to FDA, at least three serious adverse events have resulted from patients’ use of one product, colchicine, which was prepared at a concentration of 5 mg/mL but labeled as containing 0.5 mg/mL.

The recall applies to all lot numbers and codes, strengths, sizes, and expiration dates of the affected injectable products. The full recall notice and list of recalled products is available at the FDA Web site.

Phyne Refuses to Recall Adrenal Cortex Extract

6 February 2001—FDA announced Jan. 29 that Phyne is not recalling its injectable adrenal cortex abstract. This product was included in FDA's Jan. 25 list of items under recall by Phyne. 

According to FDA, the extract was manufactured by Amram under the same conditions used to prepare the other products under recall and may be unsafe. FDA advised that all remaining stocks of the extract be destroyed.