Teva Recalls Lidocaine Patches Due to Failed Stability Specifications
Teva Pharmaceuticals USA is recalling Lidocaine Patch 5% products because they failed stability specifications. The recall covers 30,382 patches distributed in the United States.
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: The agency classified this as an FDA Class III recall, which by definition is unlikely to cause adverse health consequences. The source text does not report any illnesses or injuries.
Plain-English summary
Teva Pharmaceuticals USA is recalling Lidocaine Patch 5% (700 mg) products. The recall involves 30,382 patches, specifically NDC 0591-3525-11 and NDC 0591-3525-30. The affected products are identified by Carton Lot Number 1147020B and Patch (Envelope) Lot Number 1147020.
The reason for the recall is that the products failed stability specifications. The source text does not provide further details regarding the specific nature of the stability failure or any reported adverse health events.
The affected products were distributed in the United States. Consumers and healthcare providers should check their inventory for the specific lot numbers listed above and discontinue use of the recalled products.
The recalled product
- Product
- LIDOCAINE (LIDOCAINE)
- Brand
- LIDOCAINE
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Topical Anesthetic
- Hazard
- Affected units
- 30,382
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 (1)
- Carton Lot Number:1147020B Patch (Envelope) Lot Number: 1147020
Distribution
Distribution scope not specified by the agency.
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