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Fresenius Kabi – Recall of Sensorcaine -MPF (bupivacaine) Injection
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On April 25, 2016, the FDA and Fresenius Kabi announced a voluntary, user-level recall of one lot of
Sensorcaine-MPF (bupivacaine HCl) 0.75% injection, due to visible particulate matter characterized as
glass particulate.
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The recalled product began shipping to wholesalers and distributor outlets between March 4, 2016 and
March 21, 2016. The preliminary investigation revealed that this issue is limited to the one product lot
number listed below.
Product Description
NDC #
Lot #
Sensorcaine-MPF (bupivacaine
HCl) injection 0.75%, 7.5 mg/mL, 63323-472-37 6111504
30 mL fill in a 30 mL vial
Expiration Date
09/2019
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Sensorcaine-MPF is indicated for the production of local or regional anesthesia or analgesia for surgery,
dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical
procedures.
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The potential risk to patients is considered high. Administration of a solution containing glass particulate
matter by the epidural or retrobulbar route may result in inflammation and injury, or cause blockage of
vasculature around the eye or emboli in the vasculature of eye nerves. If the particulate goes undetected
and solution is administered - depending on the particle size and number - it could block administration of
the drug to the patient, causing a delay in therapy. If the particulates are able to pass through the catheter,
it may result in local inflammation, mechanical disruption of tissue, or immune response to the particulate.
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No adverse events have been reported for this lot to date.
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Anyone with recalled product should immediately discontinue distributing, dispensing or using the affected
product, and contact Fresenius Kabi’s Quality Assurance Department at 866-716-2459 to arrange for
product return.
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For medical inquiries, contact Fresenius Kabi at 800-551-7176.
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