Revonto recall
Revonto (dantrolene sodium for injection), 20 mg/vial, For treatment of malignant hyperthermia, For Intravenous Use Only, Rx Only, Made in Italy…
Why was Revonto recalled?
Presence of Precipitate: Appearance is Out of Specification for the reconstituted solution during 24-month stability time point analysis.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: 17REV01, Exp. 12/2019
- Product
- Revonto (dantrolene sodium for injection), 20 mg/vial, For treatment of malignant hyperthermia, For Intravenous Use Only, Rx Only, Made in Italy…
- Recalling firm
- US Worldmeds LLC
- Quantity
- 6456 vials
- Distribution
- Nationwide in the USA
- Recall date
- May 8, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)