Promise Pharmacy Recalls Dexpanthenol Injection Vials Due to Sterility Concerns
Promise Pharmacy, LLC is recalling 7 vials of Dexpanthenol Injection due to a lack of sterility assurance. The product was distributed nationwide in the USA.
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. According to the rubric, an FDA Class II recall with potential for adverse health consequences (lack of sterility in an injection) maps to a score of 4 (Severe), as it is not Class I but involves a significant risk of infection or injury.
Plain-English summary
Promise Pharmacy, LLC is recalling 7 vials of Dexpanthenol, 250mg/mL Injection, 10ml vial, Rx Only. The recall is being conducted because of a lack of sterility assurance in the product. The specific lot number is 11052018@5, with a beyond-use date of 12/20/2018.
The affected product was distributed nationwide in the USA. The recall is classified as FDA Class II, which indicates a situation where 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.
Consumers and healthcare providers who have this specific lot of Dexpanthenol Injection should stop using it and contact their pharmacist or the recalling firm for instructions on how to return or dispose of the product.
The recalled product
- Product
- Dexpanthenol, 250mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
- Manufacturer
- Promise Pharmacy, LLC
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 7
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)
- Lot: 11052018@5 BUD: 12/20/2018
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 51 recalled by Promise Pharmacy, LLC 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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