LIDOLOG KIT Drug Recall Over Barcode Label Wrap Issue
Asclemed USA Inc. is recalling 18 Lidolog Kits because the label wrap covers the barcode, making it hard to scan. The recall affects products distributed within the U.S. in Tennessee.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a labeling problem where the label wrap covers the barcode, making it hard to scan, with no reported illness or injury.
Plain-English summary
Asclemed USA Inc. is recalling 18 Lidolog Kits. The product is a kit containing Lidocaine HCl Injection, USP, 2% (2mL) vial, 1 Dose, Single use Only, Rx Only, distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-760-01.
The recall is due to a labeling issue: the label wrap covers the barcode, making it hard to scan. This is classified as a labeling problem under the FDA's Not Elsewhere Classified category.
The recalled product is identified by Lot: 070126X1, Exp. 12/31/2027. The distribution is within the U.S. - Tennessee.
Consumers or healthcare providers who have questions can contact Asclemed USA Inc. The FDA classification for this recall is Class III, which typically indicates a product that is unlikely to cause adverse health consequences.
The recalled product
- Product
- LIDOLOG KIT (LIDOCAINE, KENALOG, POVIDONE IODINE)
- Brand
- LIDOLOG KIT
- Manufacturer
- Asclemed USA Inc.
- Category
- Drug — Prescription Kit
- Hazard
- Affected units
- 18
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: 070126X1
- Exp. 12/31/2027.
Distribution
Distributed in 1 state:
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