Dexamethasone Injectable Recalled for Sterility Concerns
The Compounding Shop is recalling Dexamethasone 10 mg/mL Injectable vials due to FDA inspection findings regarding quality control and lack of assurance of sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 and involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or death from infection, fitting the 'Severe' criteria for significant injury reports or high-risk defects.
Plain-English summary
The Compounding Shop, Inc. is recalling 41 vials of Dexamethasone 10 mg/mL Injectable, 2 mL vial. The product was compounded by The Compounding Shop in St. Petersburg, Florida. The recall covers all lots of this specific product.
The recall was initiated following FDA inspection findings that raised concerns regarding quality control processes. Specifically, the FDA identified a lack of assurance of sterility for the product. The agency has classified this recall as Class II.
The affected product was distributed in Florida, California, Minnesota, and Maine. Consumers and healthcare providers who have this product should stop using it and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- Dexamethasone 10 mg/mL Injectable, 2 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
- Manufacturer
- THE COMPOUNDING SHOP, INC.
- Category
- Drug — Injectable Sterile
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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