TThe Food and Drug Administration (FDA) is urging individuals, health care organizations and medical product distributors to stop dispensing and/or distributing certain injectable medications marketed by Phyne Pharmaceuticals of Scottsdale, Arizona.
Amram Inc of Rathdrum, Idaho manufactured these products for Phyne Pharmaceuticals, who was their sole customer.
On December 14, 2000, Amram Inc notified Phyne Pharmaceuticals that Amram Inc was recalling these products because they were manufactured under sub-standard conditions.
FDA issued the warning on last Thursday because Phyne Pharmaceuticals has delayed taking prompt and appropriate action to remove these products from the market.
The nationwide recall follows FDA's recent inspections of Phyne Pharmaceuticals and Amram Inc. During the inspections, FDA found violations of requirements for good manufacturing standards for pharmaceuticals. These requirements help ensure that drug products are safe and effective. The violations FDA found demonstrate that the products lack assurance of sterility and potency.
Anyone in possession of these products is urged to contact and to return the products to Phyne Pharmaceuticals at 7950 East Red Field Rd., Scottsdale, Ariz. 85267, (800) 345-3391 or 480-998-4142, FAX (480) 443-4775. Phyne Pharmaceuticals has stated they will be providing specific return instructions to their customers by an "Urgent Voluntary Drug Recall" letter dated January 25, 2001.
The following is the most up-to-date list of products under recall by Phyne Pharmaceuticals. Some of the products are labeled with both Amram Inc and Phyne Pharamceuticals; however, some may bear one or the other company's name as the manufacturer and/or distributor with or without the other company's name listed.
All lot numbers and codes, strengths and sizes and expiration dates of the following injectable products are included in this recall:
Adenosine Monophosphate
Ascorbic Acid Injection
Beet Ascorbic Acid Injection
Biotin
Colchicine
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
Riboflavin
Patients who believe they might have been injured by these products should immediately consult with their health care provider. FDA is aware of three serious injuries associated with the use of one of the recalled products, Colchicine, labeled as containing 5mg/ml but actually formulated at a concentration of 5mg/ml.
Any adverse reactions experienced with the use of these products should also be reported to the FDA's MEDWATCH Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MEDWATCH, HF-2, FDA 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MEDWATCH web site at www.fda.gov/medwatch.