Recalls / Class II
Class IID-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.
- Affected lot / code info
- Lot: 932333, Exp 08/04/16
Why it was recalled
Presence of Foreign Substance: customer complaint that one unit dose cup contained a small piece of cardboard contaminant.
Recalling firm
- Firm
- Safecor Health, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 317 New Boston St, N/A, Woburn, Massachusetts 01801-6231
Distribution
- Quantity
- 132 unit dose cups
- Distribution pattern
- NY
Timeline
- Recall initiated
- 2015-08-13
- FDA classified
- 2016-02-10
- Posted by FDA
- 2016-02-17
- Terminated
- 2016-02-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0657-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.