Recalls / Class II
Class IID-0636-2024
Product
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.
- Affected lot / code info
- Lot#: C274-000037397, C274-000037398, C274-000037399, C274-000037400, Exp. Date 10/14/2024.
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Fagron Compounding Services
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 8710 E 34th St N, Wichita, Kansas 67226-2636
Distribution
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-08-15
- FDA classified
- 2024-08-16
- Posted by FDA
- 2024-08-28
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0636-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.