Product: Midazolam HCl Syrup, 10 mg/5 mL, 5 mL unit dose cups, packaged in 2 shelf boxes, one shelf box containing 72 cups and one shelf box containing 60 cups, Cherry Brandy Flavor, Rx only, MFG: Roxane; PKG BY Safecor, Woburn, MA; Barcode 0054356605.
Reason for recall: Presence of Foreign Substance: customer complaint that one unit dose cup contained a small piece of cardboard contaminant.
Recall initiated: 20150813
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated