Lidocaine Injectable Recalled Due to Sterility Assurance Failure
Nephron Sterile Compounding Center recalled Lidocaine HCl Injection due to lack of sterility assurance. The recalled lot affects 65,590 pre-filled syringes distributed nationwide.
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: FDA classified this as a Class II recall for a sterility assurance failure affecting injectable medication. No illnesses or injuries are reported in the source material, making this a theoretical risk-of-harm scenario. Per the rubric, theoretical hazards without reported adverse events score as High (3).
Plain-English summary
Nephron Sterile Compounding Center LLC issued a recall of Lidocaine HCl Injection, USP, 2%, in 5 mL pre-filled syringes. The recall affects lot LI2001A (expiration date 6/8/2022) distributed nationwide in the United States. The recall was initiated due to lack of assurance of sterility for the affected product.
Lidocaine HCl Injection is a local anesthetic medication used in medical and healthcare settings for infiltration and nerve blocking. Pre-filled syringes are intended for use by healthcare professionals. The affected lot consisted of 65,590 syringes.
Patients and healthcare providers should verify that any Lidocaine HCl Injection pre-filled syringes in use are not from the recalled lot. Healthcare facilities should quarantine affected product and contact Nephron Sterile Compounding Center or the FDA with any questions regarding the recall.
The recalled product
- Product
- Lidocaine HCl Injection, USP, 2%, 100 mg/5 mL (20 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-FIlled Syringes, 6 x 5 Syringe Carton, 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
- Hazard
- sterility-failure
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)
- Lot: LI2001A
- Exp. 6/8/2022
Distribution
Distributed nationwide across the United States.
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