THERACARE Lidocaine Pain Relief Patches Recalled for Manufacturing Deviations
THERACARE MAXIMUM STRENGTH PAIN RELIEF PATCH (4% lidocaine) is being recalled nationwide due to manufacturing practice deviations. Unexo Life Sciences, the manufacturer, voluntarily initiated the recall after identifying quality control issues.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses, hospitalizations, or deaths. The recall is voluntary and precautionary, initiated by the manufacturer in response to identified manufacturing practice deviations. No evidence of actual harm to consumers exists.
Plain-English summary
THERACARE MAXIMUM STRENGTH PAIN RELIEF PATCH is a 4% lidocaine topical pain relief patch available in packages of 1 patch (NDC 71101-001-24) and 6 patches (NDC 71101-001-06). The manufacturer, Unexo Life Sciences Private Limited, voluntarily initiated a recall after identifying current good manufacturing practice (cGMP) deviations during product manufacturing.
The affected product was distributed nationwide throughout the United States, with approximately 455,536 patches involved in the recall. The manufacturer initiated the recall on October 24, 2024, and the FDA formally classified the recall as Class II on November 22, 2024.
The identified manufacturing practice deviations represent a failure to meet quality and control standards required in pharmaceutical manufacturing. The firm chose to voluntarily remove the product from the market in response to these identified issues.
The recalled product
- Product
- THERACARE MAXIMUM STRENGTH PAIN RELIEF PATCH (LIDOCAINE)
- Brand
- THERACARE MAXIMUM STRENGTH PAIN RELIEF PATCH
- Manufacturer
- Unexo Life Sciences Private Limited
- Category
- Drug — Topical
- Hazard
- manufacturing-deviation
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)
- a) UPC 8 45717 00878 5 b) UPC 8 45717 01056 6
UPCs (2)
- 845717008785
- 845717010566
Distribution
Distributed nationwide across the United States.
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