Why it was recalled
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Product description
Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 25 mg per 10 mL (2.5 mg per mL), 10 mL Single Dose Vial (NDC 63323-468-01), packaged in 25 Single Dose Vials per tray (NDC 63323-468-17), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.
Lot numbers, UPCs & expiration codes
Batch #: 6128800, exp 12/2023
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-0129-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 22, 2022
- FDA report date
- Jan 25, 2023
- Quantity
- 31,600 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Kabi USA, LLC
Original FDA data
Every field from FDA enforcement report D-0129-2023, exactly as published.
Show all FDA fields
- City
- Lake Zurich
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 91198
- Address
- 3 Corporate Dr
- Code information
- Batch #: 6128800, exp 12/2023
- Postal code
- 60047-8930
- Report date
- Jan 25, 2023
- Product type
- Drugs
- Recall number
- D-0129-2023
- Classification
- Class II
- Recalling firm
- Fresenius Kabi USA, LLC
- Product quantity
- 31,600 vials
- Termination date
- Oct 23, 2023
- Reason for recall
- Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 25 mg per 10 mL (2.5 mg per mL), 10 mL Single Dose Vial (NDC 63323-468-01), packaged in 25 Single Dose Vials per tray (NDC 63323-468-17), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Nov 22, 2022
- Initial firm notification
- Letter
- Center classification date
- Jan 13, 2023