Lidocaine HCl Injection Syringes Recalled for Sterility Assurance
Nephron Sterile Compounding Center recalls Lidocaine HCl Injection 2% syringes distributed nationwide due to lack of assurance of sterility. Affected lots should not be used.
What this means for you
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 drug recall without reported illnesses or injuries. The hazard—lack of sterility in an injectable product—represents a potential risk of serious harm (infection, sepsis), but no actual harm has been reported, placing it at Score 3 per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling Lidocaine HCl Injection, USP 2%, 100 mg/5 mL (20 mg/mL) syringes packaged in 5 x 5 mL pre-filled syringes per carton. The recall affects 64,380 syringes distributed nationwide in the USA.
The recall was initiated due to lack of assurance of sterility. Injectable drugs must meet strict sterility standards to prevent infections and other serious complications in patients.
Patients and healthcare providers in possession of affected lots (LI2007A, expiration 9/24/2022) should not use this product. Contact Nephron Sterile Compounding Center LLC for instructions on return or disposal of affected syringes.
The recalled product
- Product
- Lidocaine HCl Injection, USP 2%, 100 mg/5 mL (20 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-949-05
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Category
- Drug — Injectable / Anesthetic
- Hazard
- lack-of-sterility
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 (2)
- Lots: LI2007A
- Exp. 9/24/2022
Distribution
Distributed nationwide across the United States.
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