Compromised Quality of Fluconazole Leads to Recall from Sagent

Compromised Quality of Fluconazole Leads to Recall from Sagent
Image: Sagent Pharmaceuticals
March 9, 2016

Sagent Pharmaceuticals has announced a recall for medication that is potentially weakened.

The company is recalling one lot of Fluconazole Injection, USP (in 0.9 percent Sodium Chloride), 200mg per 100mL to the user level due to the discovery of an out-of-specification impurity result detected during routine quality testing. This impurity has been identified as Metronidazole. An elevated impurity has the potential to decrease effectiveness of the product in patients.

The lot number being recalled is 40608. The product comes in a flexible container bag with NDC 25021-113-82.

Sagent is not aware of any adverse patient events resulting from the use of the subject product lot.

Fluconazole is used for the treatment of oropharyngeal and esophageal candidiasis and cryptococcal meningitis.

Customers are being notified by fax, email, FedEx, and/or certified mail that includes arrangements for return of all recalled product. Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return the recalled lot of product.

Consumers with questions about this recall can contact Sagent Pharmaceuticals at (866) 625-1618.