Sensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Dose Vial, Rx only, Fr...
FDA Drug Recall #D-1037-2016 — Class II — April 25, 2016
Recall Summary
| Recall Number | D-1037-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 25, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Fresenius Kabi USA, LLC |
| Location | Lake Zurich, IL |
| Product Type | Drugs |
| 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
Lot / Code Information
Lot #: 6111504, Exp 09/2019
Other Recalls from Fresenius Kabi USA, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0182-2026 | Class I | Famotidine Injection, USP, 20 mg per 2 mL (10 m... | Nov 6, 2025 |
| D-0127-2023 | Class II | Sensorcaine (Bupivacaine HCl and Epinephrine In... | Nov 22, 2022 |
| D-0128-2023 | Class II | Sensorcaine (Bupivacaine HCl and Epinephrine In... | Nov 22, 2022 |
| D-0129-2023 | Class II | Sensorcaine-MPF (Bupivacaine HCl and Epinephrin... | Nov 22, 2022 |
| D-0750-2022 | Class I | Sodium Acetate Injection, USP, 400 mEq / 100 mL... | Mar 4, 2022 |
Frequently Asked Questions
Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.