Bumetanide Tablet
FDA Recall NDC 0185-0128
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Bumetanide (NDC 0185-0128). A significant event, classified as Class III, was initiated on Nov 06, 2013 by Sandoz Inc. The reported reason for this action was: "Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point, controlled room temperature conditions."
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
November 2013 Class III Recall: Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point, controlled room temperature conditions.
Recall Number
Class III Terminated
Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point, controlled room temperature conditions.
Nov 06, 2013
Dec 18, 2013
11,496 bottles (100 count) and 62 bottles (500 count)
Recall Profile & Regulatory Data
Event ID
66791
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Sandoz Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
May 29, 2014
Product Description
Bumetanide Tablets USP 0.5 mg. Rx Only, a) 100-count Bottle, b) 500-count Bottle, Sandoz Inc., Princeton, NJ 08540, NDC a) 0185-0128-01, b) 0185-0128-05
Batch or Lot Expiration Information
Lot# : a) CU6131, b) CW1161
Affected Packages Involved in this Recall
0185-0128-05Product
0185-0128-01Product
0185-0129-05Product
0185-0129-01Product
0185-0130-05Product
0185-0130-01Product
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.
