FDA-Drug2016-02-17Class II

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.

Safecor Health, LLC
Hazard

Presence of Foreign Substance: customer complaint that one unit dose cup contained a small piece of cardboard contaminant.

Sold states
NY
Affected count
132 unit dose cups
Manufactured in
317 New Boston St, N/A, Woburn, MA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0657-2016

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