FDA Drug Recalls
4 recalls · Class III, newest first
Class III · Low risk Terminated
Reason Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
Class III · Low risk Terminated
Reason Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
Class III · Low risk Terminated
Reason Labeling: Missing Label: The finished product potentially missing the labeling with the drug facts panel, bar code and directions for use.
Class III · Low risk Terminated
Reason Superpotent; sodium benzoate preservative