Injectables recalled, three injured

03/01/2001

FDA says GMP violations are to blame

Mark A. DeSorbo

ROCKVILLE, MD—Although a voluntary recall was issued on 39 injectables in mid-December, the U.S. Food and Drug Administration (FDA) recently issued an urgent warning that called for distribution of the medicines to cease, saying Phyne Pharmaceuticals (Scottsdale, AZ) "delayed taking prompt and appropriate action" to remove the products it paid AMRAM Inc. (Rathdrum, ID) to manufacture.

FDA spokesman Jason Brodski says one of the injectables, Colchicine, which is used to treat gout, was labeled as containing 0.5mg/ml, but was actually formulated at a concentration of 5mg/ml.

Three people, he says, became seriously ill because of the miscalculation. Although the condition of one person was not available, two people were admitted last December to Paoli Memorial Hospital (Paoli, PA), where they were listed in critical condition, a spokesman said. They were later transferred to the Hospital of the University of Pennsylvania in Philadelphia and then released.

Brodski says the injectables were manufactured under substandard conditions, and nationwide recalls follow FDA inspections of Phyne and AMRAM. During the inspections, FDA found violations of requirement for good manufacturing practices.

"These products lacked assurance of sterility and potency," Brodski adds.

Along with Colchicine, the following injectables have also been recalled: Adenosine Monophosphate; Ascorbic Acid Injection; Beet Ascorbic Acid Injection; Biotin; Vitamin B-12(Cyanocobolamin); Dexpanthenol; Disol, USP Brand of EDTA; Echinacea Homeopathic Injection; Edetate Disodium Endocrine; Adrenal Cortex Extract (ACE); Folic Acid; Germanium Sesg.(Sesguloxide); L-Glutathione or Glutathione; Human Chorionic Gonadotropin; Hydrochloric Acid; Iron 59 Injection; Liver Injection, Crude; Lypo-Vite Injection; Magnesium Chloride Injection; M.I.C.; Procaine Hydrochloride Injection; Pyridoxine HCL (B-6); Sodium Thiosalicylate; Superoxide Dismutase (S.O.D.); L-Taurine Injection; Thiamine HCL; Thymus Extract; Choline Chloride; Diphenhydramine; Glycyrrhizen; Chlorpheniramine Injection; Hydrogen Peroxide; Hydroxocobalamin; MIC with Folic Acid; Niacin; Pangamic Acid; and Riboflavin

Any adverse reactions experienced with the use of these products should also be reported to the FDA's MEDWATCH Program at 1-800-FDA-1088, 1-800-FDA-0178 (fax). Write to MEDWATCH, HF-2, FDA 5600 Fishers Lane, Rockville, MD 20852-9787, or log on to the MEDWATCH Web site at www.fda.gov/medwatch.