Bumetanide Tablets USP 0.5 mg recall
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)…
Why was Bumetanide Tablets USP 0.5 mg 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: a) CU6131, b) CW1161
- 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)…
- Recalling firm
- Sandoz Inc
- Quantity
- 11,496 bottles (100 count) and 62 bottles (500 count)
- Distribution
- Nationwide
- Recall date
- December 18, 2013
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)