Attix Pharmaceuticals Recalls Unregistered Mycophenolate Mofetil Bulk Powder
Attix Pharmaceuticals is recalling Mycophenolate Mofetil bulk powder due to cGMP deviations and lack of FDA registration.
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 FDA classified this recall as Class III, which indicates that use of or exposure to the product is not likely to cause adverse health consequences.
Plain-English summary
Attix Pharmaceuticals Inc is recalling Mycophenolate Mofetil, Bulk Powder, Quantity 1000 g. The product is intended for prescription compounding use and medical manufacturing or processing only. The specific lot number is A3160A, with manufacturer batch number 151201 and an expiry date of November 2017.
The recall was initiated because of a Current Good Manufacturing Practice (cGMP) deviation. Additionally, the manufacturer is not registered with the U.S. Food and Drug Administration. The agency has classified this recall as Class III.
This recall affects the distribution of the product in Colorado. Consumers and healthcare providers should stop using the affected product and contact their supplier or the recalling firm for further instructions.
The recalled product
- Product
- Mycophenolate Mofetil, Bulk Powder, Quantity 1000 g, For prescription compounding use and medical manufacturing or processing only, Attix Pharmaceuticals, Toronto, Canada
- Manufacturer
- Attix Pharmaceuticals Inc
- Category
- Drug — Bulk Powder
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 (3)
- Lot Number: A3160A
- Manufacturer batch number: 151201
- Expiry November 2017
Distribution
Distributed in 1 state:
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