Drug recall D-1037-2016
Product
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
Reason for recall
Presence of Particulate Matter: Glass particulate found in sterile injectable product
Lots and codes
Lot #: 6111504, Exp 09/2019
Recall details
- Recalling firm
- Fresenius Kabi USA, LLC, Lake Zurich, IL
- Quantity
- 69225 units
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 25, 2016
- Terminated
- October 20, 2016
Related products
- Sensorcaine – drug information
- NDC 63323-472 Sensorcaine Mpf · Bupivacaine Hydrochloride 7.5 mg/mL · Fresenius Kabi USA, LLC
- NDC 63323-461 Sensorcaine · Bupivacaine Hydrochloride 2.5 mg/mL; Epinephrine Bitartrate… · Fresenius Kabi USA, LLC
- NDC 63323-468 Sensorcaine Mpf · Bupivacaine Hydrochloride 2.5 mg/mL; Epinephrine Bitartrate… · Fresenius Kabi USA, LLC
- NDC 63323-463 Sensorcaine · Bupivacaine Hydrochloride 5 mg/mL; Epinephrine Bitartrate… · Fresenius Kabi USA, LLC