Recalls / Class II
Class IID-0437-2017
Product
Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-4297-31.
- 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# 660833A, Exp 08/31/18
Why it was recalled
Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.
Recalling firm
- Firm
- Roxane Laboratories, Inc.
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1809 Wilson Rd, N/A, Columbus, Ohio 43228-9579
Distribution
- Quantity
- 6493 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2016-12-22
- FDA classified
- 2017-01-23
- Posted by FDA
- 2017-02-01
- Terminated
- 2017-12-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0437-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.