Why it was recalled
Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point, controlled room temperature conditions.
Product description
Bumetanide Tablets USP 0.5 mg. Rx Only, a) 100-count Bottle, b) 500-count Bottle, Sandoz Inc., Princeton, NJ 08540, NDC a) 0185-0128-01, b) 0185-0128-05
Lot numbers, UPCs & expiration codes
Lot #: a) CU6131, b) CW1161
Where it was sold
Nationwide
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-341-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 6, 2013
- FDA report date
- Dec 18, 2013
- Quantity
- 11,496 bottles (100 count) and 62 bottles (500 count)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sandoz Inc
Original FDA data
Every field from FDA enforcement report D-341-2014, exactly as published.
Show all FDA fields
- City
- Wilson
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 66791
- Address
- 4700 Sandoz Dr
- Code information
- Lot #: a) CU6131, b) CW1161
- Postal code
- 27893-8143
- Report date
- Dec 18, 2013
- Product type
- Drugs
- Recall number
- D-341-2014
- Classification
- Class III
- Recalling firm
- Sandoz Inc
- Product quantity
- 11,496 bottles (100 count) and 62 bottles (500 count)
- Termination date
- May 29, 2014
- Reason for recall
- Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point, controlled room temperature conditions.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Bumetanide Tablets USP 0.5 mg. Rx Only, a) 100-count Bottle, b) 500-count Bottle, Sandoz Inc., Princeton, NJ 08540, NDC a) 0185-0128-01, b) 0185-0128-05
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 6, 2013
- Initial firm notification
- Letter
- Center classification date
- Dec 6, 2013