Class II · Moderate risk Terminated
Revonto
Reason cGMP deviations: Temperature abuse
Revonto
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Precipitate: Appearance is Out of Specification for the reconstituted solution during 24-month stability time point analysis.
What was recalled
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
- Recalling firm
- US Worldmeds LLC
- Origin
- KY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1275-2019
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Dantrolene recalls
See all
Class II · Moderate risk Terminated
Revonto
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Dantrolene Sodium
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk Terminated
Dantrolene Sodium
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk Terminated
Dantrolene Sodium active pharmaceutical ingredient packaged in…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.