CLASS II Drug recall · Reported 4 Dec 2019 · FDA Enforcement Report
Lidocaine HCl Injection, USP, 2% 100 mg/ (20 mg/mL) recalled
AuroMedics Pharma is recalling Lidocaine HCl Injection, USP, 2% 100 mg/ (20 mg/mL), Preservative-Free, distributed nationwide in the US. The recall was initiated on 11 Nov 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0573-2020
- FDA event ID
- 84241
- Recalling firm
- AuroMedics Pharma, East Windsor, NJ
- Brand
- Marlido Kit
- Manufacturer
- Advanced Rx of Tennessee, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Nov 2019
- FDA classified
- 5 Dec 2019
- Reported
- 4 Dec 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Pain Medication
Timeline
| 11 Nov 2019 | Recall initiated by company | |
| 4 Dec 2019 | Published in enforcement report | +23 days |
| 5 Dec 2019 | Classified by FDA | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Substance: Foreign material found inside the vial.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Presence of Foreign Substance: Foreign material found inside the vial.
Which lots are affected?
Batch #: CLC190049, Exp 02/2022
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Marcaine 0.24%/Ethanol 4% Injection, Rx recalled by Western Drug | Western Drug | Sterility | Nationwide |