FDA-Drug2013-12-18Class III
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
Sandoz Inc
Hazard
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.
Sold states
Nationwide
Affected count
11,496 bottles (100 count) and 62 bottles (500 count)
Manufactured in
4700 Sandoz Dr, Wilson, NC, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-341-2014Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief