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.
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