Promise Pharmacy Recalls Ipamorelin and Sermorelin Injections Due to Sterility Concerns
Promise Pharmacy is recalling 139 vials of Ipamorelin and Sermorelin injections nationwide due to a lack of sterility assurance.
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 recall is classified as FDA Class II and involves a lack of sterility assurance in an injectable medication, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
Promise Pharmacy, LLC is recalling 139 vials of Ipamorelin+Sermorelin, 15mg/15mg, injection, Rx Only. The recall was initiated because of a lack of sterility assurance in the product.
The affected product was distributed nationwide in the USA. The specific lot codes involved are 09212018@12 with a best use date of 12/20/2018, and 11062018@3 with a best use date of 6/4/2019.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Ipamorelin+Sermorelin, 15mg/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
- 139
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)
- 09212018@12 BUD: 12/20/2018
- 11062018@3 BUD: 6/4/2019
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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