Why it was recalled
Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.
Product description
Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-4297-31.
Lot numbers, UPCs & expiration codes
Lot# 660833A, Exp 08/31/18
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0437-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 22, 2016
- FDA report date
- Feb 1, 2017
- Quantity
- 6493 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Roxane Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0437-2017, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 76142
- Address
- 1809 Wilson Rd
- Code information
- Lot# 660833A, Exp 08/31/18
- Postal code
- 43228-9579
- Report date
- Feb 1, 2017
- Product type
- Drugs
- Recall number
- D-0437-2017
- Classification
- Class II
- Recalling firm
- Roxane Laboratories, Inc.
- Product quantity
- 6493 bottles
- Termination date
- Dec 18, 2017
- Reason for recall
- Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-4297-31.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Dec 22, 2016
- Initial firm notification
- Letter
- Center classification date
- Jan 23, 2017