Why it was recalled
Presence of Precipitate: Appearance is Out of Specification for the reconstituted solution during 24-month stability time point analysis.
Product description
Revonto (dantrolene sodium for injection), 20 mg/vial, For treatment of malignant hyperthermia, For Intravenous Use Only, Rx Only, Made in Italy, Dist. by: US WorldMeds, LLC, Louisville, KY 40241, NDC: 27505-003-67
Lot numbers, UPCs & expiration codes
Lot: 17REV01, Exp. 12/2019
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-1275-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 25, 2019
- FDA report date
- May 8, 2019
- Quantity
- 6456 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- US Worldmeds LLC
Original FDA data
Every field from FDA enforcement report D-1275-2019, exactly as published.
Show all FDA fields
- City
- Louisville
- State
- KY
- Status
- Terminated
- Country
- United States
- Event ID
- 82660
- Address
- 4441 Springdale Rd
- Code information
- Lot: 17REV01, Exp. 12/2019
- Postal code
- 40241-1086
- Report date
- May 8, 2019
- Product type
- Drugs
- Recall number
- D-1275-2019
- Classification
- Class II
- Recalling firm
- US Worldmeds LLC
- Product quantity
- 6456 vials
- Termination date
- Sep 17, 2022
- Reason for recall
- Presence of Precipitate: Appearance is Out of Specification for the reconstituted solution during 24-month stability time point analysis.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Revonto (dantrolene sodium for injection), 20 mg/vial, For treatment of malignant hyperthermia, For Intravenous Use Only, Rx Only, Made in Italy, Dist. by: US WorldMeds, LLC, Louisville, KY 40241, NDC: 27505-003-67
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 25, 2019
- Initial firm notification
- Letter
- Center classification date
- May 10, 2019