Bumetanide Tablets USP 0.5 mg. Rx Only, a) 100-count Bottle, b) 500-count Bottle, Sandoz Inc., Pr...
FDA Recall #D-341-2014 — Class III — November 6, 2013
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
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.
Recalling Firm
Sandoz Inc — Wilson, NC
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
11,496 bottles (100 count) and 62 bottles (500 count)
Distribution
Nationwide
Code Information
Lot #: a) CU6131, b) CW1161
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated