FDAFDA · Food and drugs·Recall number D-0657-2016
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.
Published February 17, 2016 · Recall initiated: August 13, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Foreign Substance: customer complaint that one unit dose cup contained a small piece of cardboard contaminant.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Safecor Health, LLC
- Distributor
- NY
- Lot
- Lot: 932333, Exp 08/04/16
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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