On April 2, 2012, American Regent, Inc. started a voluntary recall of certain vials of Cyanocobalamin Injection, USP, a product manufactured by Luitpold Pharmaceutical, Inc. The products included in this recall were sold to hospital or retail providers.
Cyanocobalamin is a common man-made form of vitamin B12 that is widely used in pharmaceuticals and supplements, and as a food additive. Vitamin B12 is an essential water-soluble vitamin that is commonly found in a variety of foods, such as fish, shellfish, meat, eggs, and dairy products. It is frequently used in combination with other B vitamins in vitamin B complex formulations. Vitamin B12 plays an important role in supplying essential methyl groups for protein and DNA synthesis.
When a person does not consume enough vitamin B12 in his or her diet, certain health-related side effects may occur. For women who are pregnant, low levels of vitamin B12 may increase the risk of brain or spinal cord defects, including spina bifida, in the baby. Also, vitamin B12 deficiency may cause hearing loss. In addition other health concerns such as cardiovascular disease, learning disorders, osteoporosis, heart failure, certain eye disorders and stroke may have an increased risk of occurrence in individuals who experience vitamin B12 deficiency.
Too much vitamin B12 in the body may also be a health concern. Some studies have linked high levels of vitamin B12 with an increased risk of prostate or lung cancer. Also, high levels of vitamin B12 in the blood have been associated with poor survival in liver cancer patients.
Fortunately, the human body stores several years' worth of vitamin B12 in the liver, so deficiency of this vitamin rarely occurs on its own. However, deficiency may result from other conditions that cause the body to become unable to use vitamin B12 that is consumed. For instance, the inability to absorb vitamin B12 from the intestinal tract can be caused by a certain type of anemia. Also, vitamin B12 deficiency is common in the elderly, who experience long-term inflammation of the lining of the stomach more often than younger individuals. This long-term inflammation may indirectly lead to digestive problems, including the inadequate absorption of vitamin B12. Finally, vitamin B12 deficiency is also common in HIV-infected patients, as well as strict vegetarians or even lactovegetarians.
People who experience significant vitamin B12 deficiency that is caused by factors such as certain anemia, digestive dysfunction, tapeworm infections, cancer of the pancreas or bowel, or folic acid deficiency may need to take products such as cyanocobalamin to treat their condition. Cyanocobalamin Injection, USP is one such product.
American Regent has recalled certain batches of its cyanocobalamin products due to the possibility that cracks may be present at the bottom and on the sides of the vials. It is believed that these cracks may cause the product to become unsterile or the cyanocobalamin solution to become contaminated with glass particles.
The specific products that have been recalled are lots #1622 (expiration date November 2013), #1679 (expiration date November 2013) and #1983 (expiration date November 2013) of Cyanocobalamin Injection, UPS, 1000mcg/mL, 1mL vial (NDC #0517-0031-25).
Any hospitals, pharmacies, clinics or doctor offices are advised to discontinue using any American Regent Cyanocobalamin Injection with these lot numbers. American Regent will credit accounts for unused products that are returned to the company.
For more information about vitamin B12, please visit Natural Standard's Foods, Herbs & Supplements Database.