Fluconazole Tablet
FDA Recall NDC 55111-145
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 4 recorded enforcement report(s) associated with Fluconazole (NDC 55111-145). A significant event, classified as Class II, was initiated on Dec 28, 2016 by Dr. Reddy's Laboratories Limited. The reported reason for this action was: "Failed Dissolution Specifications; 18 month stability time point"
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
December 2016 Class II Recall: Failed Dissolution Specifications; 18 month stability time point
Recall Number
Class II Terminated
Failed Dissolution Specifications; 18 month stability time point
Dec 28, 2016
Feb 08, 2017
59,440 blister cards
Recall Profile & Regulatory Data
Event ID
76122
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Oct 19, 2017
Product Description
Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India --- NDC 55111-145-12
Batch or Lot Expiration Information
Lot# C500222, C500515, and C500517, exp 12/2016, C502343, exp 03/2017
Affected Packages Involved in this Recall
55111-143-30Product
55111-143-01Product
55111-143-05Product
55111-143-79Product
55111-143-78Product
55111-144-30Product
55111-144-01Product
55111-144-05Product
55111-144-79Product
55111-144-78Product
55111-145-71Product
55111-145-12Product
55111-146-30Product
55111-146-01Product
55111-146-05Product
55111-146-79Product
55111-146-78Product
December 2016 Class II Recall: Failed Dissolution Specifications; 18 month stability time point
Recall Number
Class II Terminated
Failed Dissolution Specifications; 18 month stability time point
Dec 28, 2016
Feb 08, 2017
a) 2472 bottles, b) 780 bottles
Recall Profile & Regulatory Data
Event ID
76122
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Oct 19, 2017
Product Description
Flucanozole Tablets, USP, 50 mg, a) 30 count (NDC 55111-143-30) and b) 100 count (NDC 55111-143-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India
Batch or Lot Expiration Information
Lot# a) 30 count C500221, exp 12/2016, C502342, exp 03/2017 b) 100 count C500221, exp 12/2016, C502342, exp 03/2017
Affected Packages Involved in this Recall
55111-143-30Product
55111-143-01Product
55111-143-05Product
55111-143-79Product
55111-143-78Product
55111-144-30Product
55111-144-01Product
55111-144-05Product
55111-144-79Product
55111-144-78Product
55111-145-71Product
55111-145-12Product
55111-146-30Product
55111-146-01Product
55111-146-05Product
55111-146-79Product
55111-146-78Product
December 2016 Class II Recall: Failed Dissolution Specifications; 18 month stability time point
Recall Number
Class II Terminated
Failed Dissolution Specifications; 18 month stability time point
Dec 28, 2016
Feb 08, 2017
a) 38,832 and b) 5,064 bottles
Recall Profile & Regulatory Data
Event ID
76122
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Oct 19, 2017
Product Description
Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 count (NDC 55111-146-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India
Batch or Lot Expiration Information
Lot# a) 30 count C500228, exp 12/2016, C500848 and C500850, exp 01/2017 C503651 and C503653, exp 04/2017, b) 100 count C500226, exp 12/2016, C500848, C500850, exp 01/2017, C503649 and C503653, exp 04/2017
Affected Packages Involved in this Recall
55111-143-30Product
55111-143-01Product
55111-143-05Product
55111-143-79Product
55111-143-78Product
55111-144-30Product
55111-144-01Product
55111-144-05Product
55111-144-79Product
55111-144-78Product
55111-145-71Product
55111-145-12Product
55111-146-30Product
55111-146-01Product
55111-146-05Product
55111-146-79Product
55111-146-78Product
December 2016 Class II Recall: Failed Dissolution Specifications; 18 month stability time point
Recall Number
Class II Terminated
Failed Dissolution Specifications; 18 month stability time point
Dec 28, 2016
Feb 08, 2017
a) 42,984 and b) 7,764 bottles
Recall Profile & Regulatory Data
Event ID
76122
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Oct 19, 2017
Product Description
Flucanozole Tablets, USP, 100 mg, a) 30 count (NDC 55111-144-30) and b) 100 count (NDC 55111-144-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India
Batch or Lot Expiration Information
Lot# a) 30 count C500224, exp 12/2016, C500846, exp 01/2017 b) 100 count C500224, exp 12/2016, exp 12/2016, C501608, exp 02/2017 and C503655, exp 04/2017
Affected Packages Involved in this Recall
55111-143-30Product
55111-143-01Product
55111-143-05Product
55111-143-79Product
55111-143-78Product
55111-144-30Product
55111-144-01Product
55111-144-05Product
55111-144-79Product
55111-144-78Product
55111-145-71Product
55111-145-12Product
55111-146-30Product
55111-146-01Product
55111-146-05Product
55111-146-79Product
55111-146-78Product
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.
