AuroMedics Recalls MARLIDO KIT Vials Due to Foreign Material Presence
AuroMedics Pharma LLC is recalling MARLIDO KIT vials because foreign material was found inside the vials. The affected product is Lidocaine HCl Injection, USP, 2%.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which per the rubric corresponds to a 'Severe' severity score (4) when associated with potential adverse health consequences, even if specific hospitalization reports are not detailed in the provided text snippet.
Plain-English summary
AuroMedics Pharma LLC is recalling MARLIDO KIT (MARCAINE, LIDOCAINE, POVIDONE IODINE) due to the presence of foreign material found inside the vials. The specific product affected is 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. The recall involves 111,850 vials with Batch # CLC190049 and an expiration date of 02/2022.
The product is a prescription-only medication distributed nationwide in the USA. It is indicated for epidural, infiltration, and topical routes of administration. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients should stop using the affected MARLIDO KIT vials immediately. Consumers should check their inventory for the specific batch number and expiration date listed above. If the product is found, it should be returned to the distributor or disposed of according to local regulations for pharmaceutical waste.
The recalled product
- Product
- MARLIDO KIT (MARCAINE, LIDOCAINE, POVIDONE IODINE)
- Brand
- MARLIDO KIT
- Manufacturer
- AuroMedics Pharma LLC
- Category
- Drug — Injection
- Hazard
- Affected units
- 111,850
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)
- Batch #: CLC190049
- Exp 02/2022
Distribution
Distributed nationwide across the United States.
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