Compounded Ascorbic Acid Injectable Recalled for Sterility Concerns
The Compounding Shop is recalling compounded Ascorbic Acid 500 mg/mL injectable vials due to FDA inspection findings regarding 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 source text explicitly states the agency classification is Class II. According to the rubric, if the agency's own classification is FDA Class I or USDA Class I, the score is never below 4. Since this is a Class II recall involving a sterile injectable product with sterility concerns, it falls under the 'Severe' category (Score 4) as it represents a significant risk, though not explicitly Class I.
Plain-English summary
The Compounding Shop, Inc. is recalling Ascorbic Acid 500 mg/mL Injectable, 100 mL and 500 mL vials. The recall involves 78 vials of 500 mL and 92 vials of 100 mL. The product was distributed in Florida, California, Minnesota, and Maine.
The recall was initiated following FDA inspection findings that raised concerns regarding quality control processes and the assurance of sterility. The agency has classified this recall as Class II.
Healthcare providers and patients who have received this product should contact their healthcare provider for guidance. The source text does not specify specific consumer actions beyond the general recall notice.
The recalled product
- Product
- Ascorbic Acid 500 mg/mL Injectable, 100 mL and 500 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
- Manufacturer
- THE COMPOUNDING SHOP, INC.
- Category
- Drug — Compounded 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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