Why it was recalled
Low out of specification results for epinephrine assay.
Product description
Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300 mg/30 mL, (10 mg/mL), 30 mL Single Dose Vial, 25 Vials per Tray, Rx only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047. Vial NDC 63323-487-07, Tray NDC 63323-487-37
Lot numbers, UPCs & expiration codes
Batch, expiry: Batch 6123435, exp 01/2022; 6124730, 6124731, exp 07/2022
Where it was sold
Distributed 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-0651-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 25, 2021
- FDA report date
- Jul 14, 2021
- Quantity
- 234,800 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Kabi USA LLC
Original FDA data
Every field from FDA enforcement report D-0651-2021, exactly as published.
Show all FDA fields
- City
- Melrose Park
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 88194
- Address
- 2020 N Ruby St
- Code information
- Batch, expiry: Batch 6123435, exp 01/2022; 6124730, 6124731, exp 07/2022
- Postal code
- 60160-1112
- Report date
- Jul 14, 2021
- Product type
- Drugs
- Recall number
- D-0651-2021
- Classification
- Class II
- Recalling firm
- Fresenius Kabi USA LLC
- Product quantity
- 234,800 vials
- Termination date
- Dec 28, 2022
- Reason for recall
- Low out of specification results for epinephrine assay.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300 mg/30 mL, (10 mg/mL), 30 mL Single Dose Vial, 25 Vials per Tray, Rx only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047. Vial NDC 63323-487-07, Tray NDC 63323-487-37
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Jun 25, 2021
- Initial firm notification
- Letter
- Center classification date
- Jul 7, 2021