Lidocaine HCL Sterile Injection recalled for sterility assurance concerns
Tailstorm Health INC is recalling Lidocaine HCL Sterile Injection (20 mg/mL) due to FDA inspection findings of concerns with the sterile manufacturing process. The recalled product is distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall. Lidocaine HCL is an injectable pharmaceutical with a lack of sterility assurance from a manufacturing defect, which poses a serious risk of infection if administered. This meets the threshold for Severe under the rubric.
Plain-English summary
Tailstorm Health INC is recalling Lidocaine HCL Sterile Injection, USP, 20 mg/mL (200 mg/10 mL), in 10 mL sterile single-dose vials. The product is used for infiltration and nerve block procedures, including caudal and epidural use. Lot #2504003 with expiration date 04/03/2027 (NDC 81483-0001-0) is affected. Approximately 4,875 vials have been distributed nationwide in the United States.
The recall was initiated following an FDA inspection that revealed concerns with the sterile manufacturing process, which creates a lack of assurance of sterility for the product.
Consumers and healthcare providers in possession of this product should stop using it and contact Tailstorm Health INC or their supplier for instructions on return or disposal.
The recalled product
- Product
- LIDOcaine HCL Sterile Injection, USP, 20 mg/mL, 2%, (200 mg/10 mL), For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative Free, 10mL Sterile Single-Dose Vial, Rx Only, Medivant Healthcare, 158 S. Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0001-0.
- Manufacturer
- Tailstorm Health INC
- Hazard
- sterility-assurance
- contamination-risk
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 #: 2504003
- Exp. 04/03/2027
Distribution
Distributed nationwide across the United States.
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