Sodium EDTA Injectable Recalled Due to Sterility Concerns
The Compounding Shop is recalling 43 vials of Sodium EDTA Injectable because FDA inspections raised concerns about quality control and sterility assurance.
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 sterile injectable product where sterility assurance is compromised, posing a significant risk of infection or serious injury.
Plain-English summary
The Compounding Shop, Inc. is recalling 43 vials of Sodium EDTA 150 mg/mL Injectable, 250 mL vial. The product was compounded in St. Petersburg, Florida, and distributed to locations in Florida, California, Minnesota, and Maine. All lots are affected by this recall.
The recall was initiated following FDA inspection findings that resulted in concerns regarding quality control processes and the assurance of sterility for the injectable product. The agency has classified this recall as Class II.
Healthcare providers and patients who have received or possess this product should stop using it and contact their healthcare provider or the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Sodium EDTA 150 mg/mL Injectable, 250 mL vial, 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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