American Regent issued a voluntary recall for several lots of Cyanocobalamin Injection, USP because cracks may form in the bottom and sides of some of the vials.
The cracks in the vials may lead to a lack of assurance of sterility and the possibility for development of glass particulates, according to a press release from the company. This may lead to a systematic infection, abscess formation, or infection at the injection site. A patient may also experience muscle and adipose tissue damage from the defective vials.
Cyanocobalamin is used to treat people with vitamin B12 deficiencies due to malabsorption.
There are no reports of injuries associated with the drug recall.
The company is not foreign to drug recalls as it recently issued a recall for the injectable medication Phenylephrine USP for similar reasons.