Class II · Moderate risk Terminated
Revonto (dantrolene sodium for injection), 20 mg/vial, 6-count box, Rx only, MFG: US WorldMeds, Inc., NDC 78670-003-67
Reason cGMP deviations: Temperature abuse
Is Dantrolene recalled?
6 FDA recalls mention Dantrolene. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Dantrolene.
Class II · Moderate risk Terminated
Revonto (dantrolene sodium for injection), 20 mg/vial, 6-count box, Rx only, MFG: US WorldMeds, Inc., NDC 27505-003-67
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Revonto (dantrolene sodium for injection), 20 mg/vial, For treatment of malignant hyperthermia, For Intravenous Use Only, Rx…
Reason Presence of Precipitate: Appearance is Out of Specification for the reconstituted solution during 24-month stability time point analysis.
Class II · Moderate risk Terminated
Dantrolene Sodium (Orange) active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix…
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…
Class II · Moderate risk Terminated
Dantrolene Sodium (Light Yellow) active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix…
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…
Class II · Moderate risk Terminated
Dantrolene Sodium active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184…
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…
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.