Why it was recalled
Presence of Particulate Matter: Glass particulate found in sterile injectable product
Product description
Sensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Dose Vial, Rx only, Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-472-37
Lot numbers, UPCs & expiration codes
Lot #: 6111504, Exp 09/2019
Where it was sold
Nationwide
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-1037-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 25, 2016
- FDA report date
- Jun 22, 2016
- Quantity
- 69225 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Kabi USA, LLC
Original FDA data
Every field from FDA enforcement report D-1037-2016, exactly as published.
Show all FDA fields
- City
- Lake Zurich
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 73935
- Address
- 3 Corporate Dr
- Code information
- Lot #: 6111504, Exp 09/2019
- Postal code
- 60047-8930
- Report date
- Jun 22, 2016
- Product type
- Drugs
- Recall number
- D-1037-2016
- Classification
- Class II
- Recalling firm
- Fresenius Kabi USA, LLC
- Product quantity
- 69225 units
- Termination date
- Oct 20, 2016
- Reason for recall
- Presence of Particulate Matter: Glass particulate found in sterile injectable product
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Dose Vial, Rx only, Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-472-37
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 25, 2016
- Initial firm notification
- Letter
- Center classification date
- Jun 16, 2016