Promise Pharmacy Recalls Epithalon Injections Due to Sterility Concerns
Promise Pharmacy, LLC is recalling Epithalon 15mg injections due to a lack of sterility assurance. The affected lots were distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as lack of sterility assurance in an injectable drug) are classified as Severe (Score 4), as they are not explicitly Class I but involve significant risk.
Plain-English summary
Promise Pharmacy, LLC is voluntarily recalling Epithalon, 15mg injection, Rx Only. The recall is being conducted because of a lack of sterility assurance in the product. The affected product consists of 30 vials per package.
The recall covers two specific lots: Lot 09212018@11 with a beyond-use date of 12/20/2018, and Lot 11132018@4 with a beyond-use date of 2/11/2019. These products were distributed nationwide in the United States.
Consumers and healthcare providers should stop using the affected Epithalon injections and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Epithalon, 15mg injection, 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
- 30
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 (2)
- Lots: 09212018@11 BUD: 12/20/2018
- 11132018@4 BUD: 2/11/2019
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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