Why it was recalled
Lack of Assurance of Sterility
Product description
Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx only, Fagron Sterile Services, 8710 E. 34th St, N. Wichita, KS 57226.
Lot numbers, UPCs & expiration codes
Lot#: C274-000037397, C274-000037398, C274-000037399, C274-000037400, Exp. Date 10/14/2024.
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-0636-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 15, 2024
- FDA report date
- Aug 28, 2024
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fagron Compounding Services
Original FDA data
Every field from FDA enforcement report D-0636-2024, exactly as published.
Show all FDA fields
- City
- Wichita
- State
- KS
- Status
- Ongoing
- Country
- United States
- Event ID
- 95146
- Address
- 8710 E 34th St N
- Code information
- Lot#: C274-000037397, C274-000037398, C274-000037399, C274-000037400, Exp. Date 10/14/2024.
- Postal code
- 67226-2636
- Report date
- Aug 28, 2024
- Product type
- Drugs
- Recall number
- D-0636-2024
- Classification
- Class II
- Recalling firm
- Fagron Compounding Services
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx only, Fagron Sterile Services, 8710 E. 34th St, N. Wichita, KS 57226.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Aug 15, 2024
- Initial firm notification
- Letter
- Center classification date
- Aug 16, 2024