Lidocaine HCl Injection Recall Due to Lack of Sterility Assurance
Fagron Compounding Services is recalling Lidocaine HCl Injection due to lack of assurance of sterility. Four lot numbers distributed nationwide are affected with expiration date 10/14/2024.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of an injectable product without assured sterility. No illnesses or injuries have been reported. This constitutes a risk-of-harm product where injury has not yet been reported, meeting the rubric criteria for High severity.
Plain-English summary
Fagron Compounding Services is recalling Lidocaine HCl Injection, 2% (20mg per mL), supplied as 100 mg per 5 mL per syringe, due to lack of assurance of sterility. The affected product was distributed nationwide in the United States.
The recall involves four specific lot numbers: C274-000037397, C274-000037398, C274-000037399, and C274-000037400, all with an expiration date of 10/14/2024. Sterility assurance is critical for injectable medications to prevent serious infections.
Consumers and healthcare providers who have obtained this product with the affected lot numbers should stop using it immediately and contact Fagron Compounding Services or their healthcare provider for guidance on replacement or disposal.
The recalled product
- 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.
- Manufacturer
- Fagron Compounding Services
- Category
- Drug — Injectables
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot#: C274-000037397
- C274-000037398
- C274-000037399
- C274-000037400
- Exp. Date 10/14/2024.
Distribution
Distributed nationwide across the United States.
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