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SafetyAlerts
December 23, 2000

URGENT: Drug Recall Announced by FDA

Scottsdale, AZ (SafetyAlerts) - Phyne Pharmaceuticals has initiated a recall of the following injectable products due to the lack of Current Good Manufacturing Practice (CGMP) compliance at its contract manufacturing site in Rathdrum, ID (Amram, Inc). The lack of CGMP's includes, but is not limited to, the lack of assurance of sterility in these injectable products and super-potency of its Colchicine product labeled as .5 mg/mL, but actually formulated at 5 mg/mL.

It is important that you immediately examine your drug supplies for any of these products and if found, discontinue dispensing or use and return them to Phyne Pharmaceuticals. You should receive return instructions from Phyne Pharmaceuticals shortly.

If you have further distributed any of these products, immediately contact your accounts and advise them of the recall situation.

Please note: This is the most up to date list of products (not in alphabetical order) under recall by Phyne Pharmaceuticals. FDA inspections continue and there may be minor changes issued in the following days. Some products are labeled with both AMRAM, Inc and Phyne Pharmaceuticals; 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/codes and expiration dates of the following injectable products are included in this recall:
Adenosine Mono-phosphate, 25 mg/mL, 30 mL vial
Ascorbic Acid Injection, 500 mg/mL, 50 mL vial
Beet Ascorbic Acid Injection, USP-500 mg/mL, 50 mL vial
Biotin, 10 mg/mL, 30 mL Injection
Colchicine, .5 mg/mL, 30 ml multi dose vial
Vitamin B-12 5000, 100 mL Injection, (Cyanocobolamin 5000 mg/mL)
Dexpanthenol, 250 mg/mL, Injection preserved, 30 mL vial
Disol, USP Brand of EDTA, 150 mg/mL-100 mL vial
Echinacea (2X) Homeopathic Injection, 30 mL Multi-Dose Vial, contents per mL 1:1 Macerated (2X)
Edetate Disodium Injection, USP, 3g/20mg (150mg/mL)-20 mL vial
Endocrine, 30 mL vial - Note: this product was also distributed as Adrenal Cortex Extract (ACE) 30 mL
Folic Acid, 10 mg/mL, 30 mL Injection
Germanium Sesg., 15.5 mg/30 ml Injection (Sesguloxide, USP)
(L) Glutathione, 60 mg/mL, 30 mL vial
Human Chorionic Gonadotropin for Injection, 10,000 units,10mL multi dose vial
Hydrochloric Acid, 2mg/mL, 100 mL vial

Iron 59 Injection, 30 ml vial. Each cc contains:

  • Ferrous Gluconate 5.9mg
  • Cobalt Gluconate 9 mg
  • Cyanocobalamin 5 mg
  • Procaine HCL 10 mg

Liver Injection, Crude, 30 mL multiple dose vial
Lypo-Vite Injection, 30 mL multi-dose vial. Each mL contains:

  • Cyanocobalamin 100 mcg
  • Riboflavin 5mg
  • Phosphate Sodium 5 mg
  • Thiamine HCL 50 mg
  • Pyridoxine HCL 5 mg
  • d-Panthenol 5mg
  • Ascorbic Acid 50 mg
  • Choline Chloride 100mg
  • Insitol 50mg
  • DL-Methionine 25mg
  • Benzyl Alcohol 1.5%

Magnesium Chloride Injection, 200 mg/mL, 50mL multi dose vial M.I.C. 50mL vial, Each 2mL contains:

  • L-Methionine 50 mg
  • Inositol 100 mgCholine
  • Chloride 100 mg
  • Benzyl Alcohol 1.5%

Procaine Hydrochloride Injection, USP, 2%, 100mL Multi Dose vial

Pyridoxine HCL (B-6), 100 mg/mL 30 mL Injection
Sodium Thiosalicylate, 30mL Injection
Superoxide Dismutase (S.O.D.), 10 mg/mL, 30 mL multi-dose vial
L-Taurine Injection, 50 mg/mL, 100 mL vial & 30 mL vial
Thiamine HCL, 100 mg/mL, 30 mL Injection B-1, 100 mL vial & 200 mg/mL
Thymus Extract, 10 mg/mL, 30 mL multi-dose vial
Choline Chloride, 30 mL vial
Diphenhydramine, 30 mL vial
Glycyrrhizen, 30 mL vial
Chlorpheniramine Injection, (strength and size unknown at this time)
Hydrogen Peroxide, 11 cc per 100 mL vial
Hydroxocobalamin, 30 mL vial
MIC with Folic Acid, 50 mL vial
Niacin, 30 mL
Pangamic Acid, 500 mg/ml, 30 mL vial
Riboflavin, 30 mL vial

Any adverse reactions experienced with the use of these products should 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 website at www.fda.gov/medwatch.

DISTRIBUTOR/RECALLING FIRM:
Phyne Pharmaceuticals, Inc.
7950 East Red Field Rd.
Scottsdale, AZ
800-345-3301 or 602-998-4142
FAX-602-443-4775

MANUFACTURER:
AMRAM, Inc
Rathdrum, ID

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.