D-1037-2016 Class II Terminated
FDA drug recall D-1037-2016 was initiated by Fresenius Kabi USA, LLC on Apr 25, 2016 and is designated Class II. Reason for recall: Presence of Particulate Matter: Glass particulate found in sterile injectable product The recall status is terminated (terminated Oct 20, 2016). Affected quantity: 69225 units.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 22, 2016
- Initiation Date
- Apr 25, 2016
- Termination Date
- Oct 20, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 69225 units
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
Distribution Pattern
Nationwide
Code Information
Lot #: 6111504, Exp 09/2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1037-2016
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026