Dexpanthenol Injectable Recalled Due to Sterility Assurance Concerns
The Compounding Shop is recalling Dexpanthenol 200 mg/mL Injectable vials because FDA inspection findings 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 agency classification is FDA Class II. According to the rubric, an FDA Class II recall involving a drug with sterility concerns (a significant safety risk) aligns with the 'Severe' category, particularly given the potential for serious injury from non-sterile injectables, even without explicit hospitalization reports in the provided text snippet.
Plain-English summary
The Compounding Shop, Inc. is recalling Dexpanthenol 200 mg/mL Injectable, 100 mL vials. The recall affects all lots of the product. The company is the recalling firm and the manufacturer.
The recall was initiated because FDA inspection findings resulted in concerns regarding quality control processes and a lack of assurance of sterility. The source text does not specify the exact nature of the quality control failures or the specific sterility risks.
The product was distributed in Florida, California, Minnesota, and Maine. The source text does not provide specific dates of distribution or the total number of units recalled. Consumers and healthcare providers should stop using the product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Dexpanthenol 200 mg/mL Injectable, 100 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
- Manufacturer
- THE COMPOUNDING SHOP, INC.
- Category
- Drug — Injectable
- Hazard
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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