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.
FDA recall notice · announced February 17, 2016 · Safecor Health
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The 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.
Notes
Distribution: NY
Lot/code information: Lot: 932333, Exp 08/04/16
Quantity: 132 unit dose cups
Status: Terminated
Products in this recall event:
- 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 (D-0657-2016)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.