PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: February 17, 2016 Initiated: August 13, 2015 #D-0657-2016

Product Description

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.

Details

Recalling Firm
Safecor Health, LLC
Units Affected
132 unit dose cups
Distribution
NY
Location
Woburn, MA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Safecor Health, LLC. Units affected: 132 unit dose cups.
Why was this product recalled?
Presence of Foreign Substance: customer complaint that one unit dose cup contained a small piece of cardboard contaminant.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 17, 2016. Severity: Moderate. Recall number: D-0657-2016.