Recalls / Class II
Class IID-0573-2020
Product
Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free, packaged in 10 x 5 mL Single Dose Vials per carton, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-165-05.
- Brand name
- Marlido Kit
- Generic name
- Marcaine, Lidocaine, Povidone Iodine
- Route
- Epidural, Infiltration, Topical
- NDC
- 80425-0573
- Affected lot / code info
- Batch #: CLC190049, Exp 02/2022
Why it was recalled
Presence of Foreign Substance: Foreign material found inside the vial.
Recalling firm
- Firm
- AuroMedics Pharma LLC
- Manufacturer
- Advanced Rx of Tennessee, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 111,850 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2019-11-11
- FDA classified
- 2019-12-05
- Posted by FDA
- 2019-12-04
- Terminated
- 2020-11-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0573-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.