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.
Product description
FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4297-31, UPC 3 0054-4297-31 8.
Lot numbers, UPCs & expiration codes
Lot #: 559660P, 559661P, Exp 03/17
Where it was sold
Nationwide and Puerto Rico
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-0011-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 25, 2015
- FDA report date
- Oct 21, 2015
- Quantity
- 11,110 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Boehringer Ingelheim Roxane Inc
Original FDA data
Every field from FDA enforcement report D-0011-2016, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 72234
- Address
- 1809 Wilson Rd
- Code information
- Lot #: 559660P, 559661P, Exp 03/17
- Postal code
- 43228-9579
- Report date
- Oct 21, 2015
- Product type
- Drugs
- Recall number
- D-0011-2016
- Classification
- Class III
- Recalling firm
- Boehringer Ingelheim Roxane Inc
- Product quantity
- 11,110 bottles
- Termination date
- Feb 19, 2016
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4297-31, UPC 3 0054-4297-31 8.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Sep 25, 2015
- Center classification date
- Oct 9, 2015