FDA recall D-0657-2016

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.

Distribution

NY

Key facts

Status

Terminated

Initiation date

2015-08-13

Report date

2016-02-17

Termination date

2016-02-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Woburn, MA, United States

Primary source

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