The Recall Desk
SevereFDA (Drugs)·D-0855-2016·Announced 2016-05-25

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
Hazard

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.

Related recalls

Same hazard · unapproved drug

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