Fluconazole
FDA Recall NDC 59762-5016
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
The FDA has identified 1 recorded enforcement report(s) associated with Fluconazole (NDC 59762-5016). A significant event, classified as Class II, was initiated on Jan 29, 2014 by Mylan Pharmaceuticals Inc.. The reported reason for this action was: "Defective Container: Tamper evident ring failures discovered on some bottles."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Defective Container: Tamper evident ring failures discovered on some bottles.
Jan 29, 2014
Jun 11, 2014
4,155 bottles
Recall Profile & Regulatory Data
Event ID
67532
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide, Italy and Republic of South Korea
Termination Date
Mar 14, 2017
Product Description
GREENSTONE BRAND fluconazole for Oral Suspension, ORANGE FLAVORED, 40 mg/mL, when reconstituted, Rx only, Distributed by Greenstone LLC Peapack, NJ 07977. MADE IN INDIA. NDC 59762-5030-1
Batch or Lot Expiration Information
Lot# A358502; Exp 01/15
Affected Packages Involved in this Recall
59762-5015-1Product
59762-5016-1Product
59762-5017-1Product
59762-5018-1Product
59762-5029-1Product
59762-5030-1Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
