November 2013 FDA Recall Bumetanide by Sandoz Inc (D-341-2014 - 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 Class III drug recall was voluntarily initiated by Sandoz Inc on November 6, 2013 for the product Bumetanide. The FDA reported the reason for recall as 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.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-341-2014

Reason for 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.
Initiated
11-06-2013
Reported
12-18-2013
Quantity
11,496 bottles (100 count) and 62 bottles (500 count)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66791
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sandoz Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-29-2014
Product Description About Product Description
Full technical description of the product.
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

0185-0128-05 Bumetanide
0185-0128-01 Bumetanide
0185-0129-05 Bumetanide
0185-0129-01 Bumetanide
0185-0130-05 Bumetanide
0185-0130-01 Bumetanide