Reumofan Plus tablets recalled for undeclared active pharmaceutical ingredients
Reumofan Plus tablets are being recalled because they were marketed without an approved NDA/ANDA and may contain undeclared active ingredients.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Reumofan Plus USA, LLC and Reumofan USA, LLC are recalling 586 bottles of Reumofan Plus, 30-count tablets. The product was distributed nationwide through internet sales. The specific lot number is 99515, with an expiration date of 09/2016.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Additionally, the product may contain undeclared active pharmaceutical ingredients, specifically Diclofenac Sodium, Dexamethasone, and Methocarbamol.
Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- Reumofan Plus, 30-count tablets per bottle, distriubted by Reumofan Plus USA, LLC and Reumofan USA, LLC, Springfield, PA, and manufactured by Riger Natural S.A., Mexico.
- Manufacturer
- Reumofan Plus USA
- Category
- Drug — Tablets
- Affected units
- 586
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 #: 99515
- Exp 09/2016
Distribution
Distributed nationwide across the United States.
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