Recalls / Class II
Class IID-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
- Brand name
- Sensorcaine
- Generic name
- Bupivacaine Hydrochloride And Epinephrine Bitartrate
- Active ingredients
- Bupivacaine Hydrochloride, Epinephrine Bitartrate
- Route
- Infiltration, Perineural
- NDCs
- 63323-461, 63323-472, 63323-463, 63323-468
- FDA application
- ANDA070967
- Affected lot / code info
- Lot #: 6111504, Exp 09/2019
Why it was recalled
Presence of Particulate Matter: Glass particulate found in sterile injectable product
Recalling firm
- Firm
- Fresenius Kabi USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Corporate Dr, Lake Zurich, Illinois 60047-8930
Distribution
- Quantity
- 69225 units
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-04-25
- FDA classified
- 2016-06-16
- Posted by FDA
- 2016-06-22
- Terminated
- 2016-10-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1037-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.