Recalls / Class III
Class IIID-0012-2016
Product
FUROSEMIDE Tablets USP, 40 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4299-31, UPC 3 0054-4299-31 2.
- Brand name
- Furosemide
- Generic name
- Furosemide
- Active ingredient
- Furosemide
- Route
- Oral
- NDCs
- 0054-3294, 0054-4297, 0054-8297, 0054-4299, 0054-8299, 0054-4301, 0054-8301, 0054-3298
- FDA application
- ANDA070434
- Affected lot / code info
- Lot #: 559310P, Exp 02/17; 559664B, Exp 04/17
Why it was recalled
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.
Recalling firm
- Firm
- Boehringer Ingelheim Roxane Inc
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 1809 Wilson Rd, N/A, Columbus, Ohio 43228-9579
Distribution
- Quantity
- 5,160 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2015-09-25
- FDA classified
- 2015-10-09
- Posted by FDA
- 2015-10-21
- Terminated
- 2016-02-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0012-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.