SCHAUMBURG, Ill., March 01, 2016 (GLOBE NEWSWIRE) — Sagent Pharmaceuticals, Inc. today announced the designed nationwide recall of one lot of Fluconazole Injection, USP, (in 0.9% Sodium Chloride) 200mg for 100mL flexible container bag (NDC 25021-113-82) Lot 40608 manufactured by ACS Dobfar INFO S.A. and distributed through Sagent. Sagent has initiated this free-will recall of Fluconazole Injection, USP, 200mg by means of 100mL to the user level owed to the discovery of an uncovered of specification impurity result detected for the period of routine quality testing of stability samples at the 18-month intervening time. This impurity has been identified in the same proportion that Metronidazole. An elevated impurity has the possible to decrease effectiveness of the harvest in patients. Patients on the fruit and on concomitant medication of Metronidazole may have capacity for an increased dose of Metronidazole.
Sagent is not percipient of any adverse patient events resulting from the employment of the subject product lot.
The apportionment number being recalled is Lot 40608 that was distributed to hospitals, wholesalers and distributors nationwide from November 2014 through December 2014. Fluconazole Injection, USP, 200mg per 100mL is indicated, for the management of Oropharyngeal and esophageal candidiasis, cryptococcal meningitis, and is supplied in 100mL and 200mL ductile container bags.
Customers are being notified ~ means of fax, email, FedEx, and/or certified armor that includes arrangements for return of every one of recalled product. Customers have been instructed to inquire about their inventory immediately and to quarantine, discontinue distribution of and return the recalled piece of land of product. Customers who may be in actual possession of further distributed this product have been requested to ascertain to be the same their customers and notify them at once of this product recall. The that cannot be spared form by which to document this complaint as well as other information regarding this recall is available at www.Sagentpharma.com.
Any questions here and there returning unused product should be directed to the customer call center at (866) 625-1618 M-F 8am-7pm CST. Healthcare workers who be the subject of medical questions about Fluconazole Injection, USP may junction Sagent Medical Affairs (866-625-1618, Option 3) M-F 8am-5pm CST.
Consumers should contact their physician or healthcare provider whether or not they have experienced any problems that may have existence related to taking or using this issue.
Any adverse events that may have ~ing related to the use of this crops should be reported to the FDA’s MedWatch Program either online, by regular mail or ~ dint of. fax.
This recall is being conducted by the knowledge of the U.S. Food and Drug Administration.
About Sagent Pharmaceuticals, Inc.
Sagent Pharmaceuticals, Inc., founded in 2006, is a specialty pharmaceutical joint concern focused on developing, manufacturing, sourcing and marketing pharmaceutical products, with a specific emphasis on injectables. Sagent has created a peculiar global network of resources, comprising speedy development capabilities, sophisticated manufacturing and innovative mix with ~s delivery technologies, resulting in an large and rapidly expanding pharmaceutical product portfolio that fulfills the evolving necessarily of patients.
Jonathon Singer, Sagent
Customer Call Center
SAGENT MEDICAL AFFAIRS
(866) 625-1618, Option 3
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The medication can also be melted in supply with ~ and injected.