Phosphatidyl Choline Injectable Recalled for Sterility Concerns
The Compounding Shop is recalling Phosphatidyl Choline 10% Injectable 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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable product, which poses a significant risk of serious injury or hospitalization.
Plain-English summary
The Compounding Shop, Inc. is recalling Phosphatidyl Choline 10%, Injectable, 500 mL vials. The recall involves 32 vials of 50mL, covering all lots. 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. Specifically, there is a lack of assurance of sterility for the product.
Consumers who have 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
- Phosphatidyl Choline 10%, Injectable, 500 mL vial, 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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