Sandoz Recalls Bumetanide Tablets Due to Moisture Content Failures
Sandoz Inc. is recalling Bumetanide Tablets USP 0.5 mg because stability testing showed moisture content out of specification.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a stability testing failure (moisture content) without reported injuries or illnesses.
Plain-English summary
Sandoz Inc. is recalling Bumetanide Tablets USP 0.5 mg, a prescription-only medication. The recall involves 100-count and 500-count bottles distributed nationwide. The specific lots affected are CU6131 (100-count) and CW1161 (500-count).
The recall was initiated because out-of-specification (OOS) results were obtained for moisture content during stability testing at the 12-month time point under controlled room temperature conditions. This indicates the product failed to meet the required moisture limits.
Consumers and healthcare providers should stop using the affected lots and return them to the pharmacy or point of sale for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- BUMETANIDE (BUMETANIDE)
- Brand
- BUMETANIDE
- Manufacturer
- Sandoz Inc
- Category
- Drug — Prescription Medication
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: a) CU6131
- b) CW1161
UPCs (3)
- 0301850128013
- 0301850129010
- 0301850130016
Distribution
Distributed nationwide across the United States.
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