Boehringer Ingelheim Roxane Recalls Furosemide Tablets Due to Manufacturing Error
Boehringer Ingelheim Roxane Inc. is recalling 5,160 bottles of Furosemide Tablets USP because the wrong active ingredient was used during manufacturing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low probability of adverse health consequences. The hazard is a manufacturing error involving the wrong API, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Boehringer Ingelheim Roxane Inc. is recalling 5,160 bottles of Furosemide Tablets USP, 40 mg, 1000-count bottles. The affected products are distributed nationwide and in Puerto Rico. The specific lots involved are 559310P (Exp 02/17) and 559664B (Exp 04/17).
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, it should be returned to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- FUROSEMIDE (FUROSEMIDE)
- Brand
- FUROSEMIDE
- Manufacturer
- Boehringer Ingelheim Roxane Inc
- Category
- Drug — Prescription Drug
- Affected units
- 5,160
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 (4)
- Lot #: 559310P
- Exp 02/17
- 559664B
- Exp 04/17
UPCs (5)
- 0300544301251
- 0300544299251
- 0300544297257
- 0300543298637
- 300544299312
Distribution
Part of a larger recall action
This product is one of 2 recalled by Boehringer Ingelheim Roxane Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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