Drug 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.
D-0657-2016
Product summary
- Event
- Event 72970
- Status
- Terminated
- Classification
- Class II
- Quantity
- 132 unit dose cups
- Official record key
drug-enforcement:D-0657-2016
Official wording
Reason: Presence of Foreign Substance: customer complaint that one unit dose cup contained a small piece of cardboard contaminant.
Code information: Lot: 932333, Exp 08/04/16
Distribution pattern: NY
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance