Why it was recalled
Presence of Foreign Substance: customer complaint that one unit dose cup contained a small piece of cardboard contaminant.
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.
Lot numbers, UPCs & expiration codes
Lot: 932333, Exp 08/04/16
Where it was sold
NY
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0657-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 13, 2015
- FDA report date
- Feb 17, 2016
- Quantity
- 132 unit dose cups
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Safecor Health, LLC
Original FDA data
Every field from FDA enforcement report D-0657-2016, exactly as published.
Show all FDA fields
- City
- Woburn
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 72970
- Address
- 317 New Boston St
- Code information
- Lot: 932333, Exp 08/04/16
- Postal code
- 01801-6231
- Report date
- Feb 17, 2016
- Product type
- Drugs
- Recall number
- D-0657-2016
- Classification
- Class II
- Recalling firm
- Safecor Health, LLC
- Product quantity
- 132 unit dose cups
- Termination date
- Feb 25, 2016
- Reason for recall
- Presence of Foreign Substance: customer complaint that one unit dose cup contained a small piece of cardboard contaminant.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- NY
- Recall initiation date
- Aug 13, 2015
- Initial firm notification
- Letter
- Center classification date
- Feb 10, 2016