Compounded MIC Injectable Recalled Due to Sterility Concerns
The Compounding Shop is recalling MIC Injectable vials because FDA inspections raised concerns about quality control and sterility assurance.
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 rating under the rubric for significant injury or property damage risks, specifically involving sterility concerns in an injectable drug.
Plain-English summary
The Compounding Shop, Inc. is recalling MIC (Methionine, Inositol, and Choline) Injectable, 30 mL vials. The recall involves 10 vials of 30 mL each from all lots. The product was distributed in Florida, California, Minnesota, and Maine.
The recall was initiated following FDA inspection findings that resulted in concerns regarding quality control processes and the assurance of sterility for the compounded injectable product.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- MIC (Methionine, Inositol, and Choline) Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
- Manufacturer
- THE COMPOUNDING SHOP, INC.
- Category
- Drug — Injectable
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
Part of a larger recall action
This product is one of 25 recalled by THE COMPOUNDING SHOP, INC. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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