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
Reported: June 22, 2016 Initiated: April 25, 2016 #D-1037-2016
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
Reason for Recall
Presence of Particulate Matter: Glass particulate found in sterile injectable product
Details
- Recalling Firm
- Fresenius Kabi USA, LLC
- Units Affected
- 69225 units
- Distribution
- Nationwide
- Location
- Lake Zurich, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Fresenius Kabi USA, LLC. Units affected: 69225 units.
Why was this product recalled? ▼
Presence of Particulate Matter: Glass particulate found in sterile injectable product
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 22, 2016. Severity: Moderate. Recall number: D-1037-2016.
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