Why it was recalled
Subpotent Drug: Low out-of-specification assay results for the epinephrine component.
Product description
Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL (5 mg per mL), 30 mL Single Dose Vial (NDC 63323-462-01), packaged as 25 Single Dose Vials per tray (NDC 63323-462-37), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.
Lot numbers, UPCs & expiration codes
Batch # 6123760, Exp 02/2022
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0172-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 10, 2020
- FDA report date
- Dec 30, 2020
- Quantity
- 4411 trays
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Kabi USA, LLC
Original FDA data
Every field from FDA enforcement report D-0172-2021, exactly as published.
Show all FDA fields
- City
- Lake Zurich
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 86964
- Address
- 3 Corporate Dr
- Code information
- Batch # 6123760, Exp 02/2022
- Postal code
- 60047-8930
- Report date
- Dec 30, 2020
- Product type
- Drugs
- Recall number
- D-0172-2021
- Classification
- Class II
- Recalling firm
- Fresenius Kabi USA, LLC
- Product quantity
- 4411 trays
- Termination date
- Aug 25, 2022
- Reason for recall
- Subpotent Drug: Low out-of-specification assay results for the epinephrine component.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL (5 mg per mL), 30 mL Single Dose Vial (NDC 63323-462-01), packaged as 25 Single Dose Vials per tray (NDC 63323-462-37), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Dec 10, 2020
- Initial firm notification
- Letter
- Center classification date
- Dec 22, 2020