Reported Dec 18, 2013 · Terminated
Bumetanide Tablets USP 0.5 mg. Rx Only, a) 100-count Bottle, b) 500-count Bottle, Sandoz Inc., Princeton, NJ 08540, NDC…
Sandoz Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sandoz Inc · 4700 Sandoz Dr · Wilson, NC · 27893-8143
Is this the product you have?
Bumetanide Tablets USP 0.5 mg. Rx Onlya) 100-count Bottleb) 500-count BottleSandoz IncPrincetonNJ 08540NDC a) 0185-0128-01b) 0185-0128-05
- Lot codes and dates
Lot #: a) CU6131b) CW1161
- Amount recalled
- 11,496 bottles (100 count) and 62 bottles (500 count)
Where it was sold
- Nationwide
Why it was recalled
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 product is unlikely to cause harm, but it breaks a safety or labelling rule.
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