January 25, 2001FDA Re-iterates Urgent Notice of
Recalled Injectable Drugs
(SafetyAlerts) - The 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, Ariz. AMRAM Inc. of Rathdrum, Idaho
manufactured these products for Phyne Pharmaceuticals, who was their sole customer.
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.
On December 14, 2000, AMRAM Inc. notified Phyne Pharmaceuticals that AMRAM Inc. was
recalling these products (previous
notice) because they were manufactured under sub-standard conditions.
FDA is issuing today's warning 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:
Ascorbic Acid Injection
Beet Ascorbic Acid Injection
Disol, USP Brand of EDTA
Echinacea Homeopathic Injection
Adrenal Cortex Extract (ACE) (See Addendum)
L-Glutathione or Glutathione
Human Chorionic Gonadotropin
Iron 59 Injection
Liver Injection, Crude
Magnesium Chloride Injection
Procaine Hydrochloride Injection
Pyridoxine HCL (B-6)
Superoxide Dismutase (S.O.D.)
MIC with Folic Acid
See related HealthScout story HERE
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.
comprehensive safety recall information for the United States. SafetyAlerts Newsletter is a free email service to warn
consumers of faulty products and contaminated foods. For complete information regarding
current recalls, past recalls and timely product warning notification visit: www.safetyalerts.com.