D-0657-2016 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 17, 2016
- Initiation Date
- August 13, 2015
- Termination Date
- February 25, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 132 unit dose cups
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.
Distribution Pattern
NY
Code Information
Lot: 932333, Exp 08/04/16