December 2000 Recalls

December was a fairly big month for medication recalls. Getting right to it, keep in mind the classification of recalls. Some of these are more serious than others, many are just inconvenient.

On December 23, there was an urgent drug recall instituted by the FDA. This recall is not on the FDA website as of December 29. Please examine this list carefully if you use any injectable medications as the list is quite extensive. For some reason that I am not clear on, the class of recall has not been listed, but in looking at this list and the reason for the recall, I would say that it is a fairly serious situation.

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. The following products are involved: 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%

The copyright of the article December 2000 Recalls in Public Health Issues is owned by Adelle Vancil Tilton. Permission to republish December 2000 Recalls in print or online must be granted by the author in writing.

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