Fluconazole Tablet
FDA Recall NDC 0904-6501
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Fluconazole (NDC 0904-6501). A significant event, classified as Class II, was initiated on Jan 05, 2017 by Major Pharmaceuticals. The reported reason for this action was: "Failed Dissolution Specifications"
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
Failed Dissolution Specifications
Jan 05, 2017
May 10, 2017
914 cartons
Recall Profile & Regulatory Data
Event ID
77106
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
The Harvard Drug Group
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the US
Termination Date
Aug 04, 2017
Product Description
Fluconazole Tablets, USP, 200 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI 48150 USA, NDC 0904-6501-61
Batch or Lot Expiration Information
Lot# :T-00519, Exp. 01-17
Affected Packages Involved in this Recall
0904-6500-06Product
0904-6500-61Product
0904-6501-06Product
0904-6501-61Product
Class II Terminated
Failed Dissolution Specifications
Jan 05, 2017
May 10, 2017
2,341 cartons
Recall Profile & Regulatory Data
Event ID
77106
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
The Harvard Drug Group
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the US
Termination Date
Aug 04, 2017
Product Description
Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI 48150 USA, NDC 0904-6500-61
Batch or Lot Expiration Information
Lot# : T-00520, EXP 02-17, T-00632, T-00699, EXP. 04-17
Affected Packages Involved in this Recall
0904-6500-06Product
0904-6500-61Product
0904-6501-06Product
0904-6501-61Product
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.
