Renovo Patch Recalled for Lack of Approval and Subpotency
TMIG Inc is recalling Renovo Patch because it was marketed without FDA approval and three lots were found to be subpotent.
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 corresponds to a Severe severity score (4) under the rubric, particularly given the presence of subpotent lots which may result in lack of therapeutic effect.
Plain-English summary
TMIG Inc is recalling Renovo Patch (Capsaicin, 0.0375%, Menthol, USP 5.00%), a prescription-only product distributed nationwide. The recall is being conducted because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), making it an unapproved drug. Additionally, three specific lots of the product were found to be subpotent, meaning they did not contain the required amount of active ingredient.
The recall affects all lots of the product. The product is manufactured by Pocono Coated Products LLC. and distributed by TMIG Inc. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider for further instructions or a replacement if appropriate.
The recalled product
- Product
- Renovo Patch (Capsaicin, 0.0375%, Menthol, USP 5.00%), 3-count patches per carton, Rx only, Distributed By: TMIG Inc, Marietta , GA 30062, Manufactured By: Pocono Coated Products LLC., Cherryville, NC 28021 NDC: 69176-025-03
- Manufacturer
- TMIG Inc
- Category
- Drug — Topical Analgesic
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)
- All lots
Distribution
Distributed nationwide across the United States.
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