Promise Pharmacy Recalls Sermorelin Injections Due to Sterility Concerns
Promise Pharmacy, LLC is recalling 255 vials of Sermorelin 9 mg injection 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 drug, which poses a risk of serious injury or death if the product is contaminated.
Plain-English summary
Promise Pharmacy, LLC is recalling 255 vials of Sermorelin 9 mg injection, a prescription-only medication. The recall is being conducted because of a lack of sterility assurance in the product.
The affected product was distributed nationwide in the United States. The recall covers specific lots with the following identifiers and beyond-use dates: 06182018@2 (12/15/2018), 08212018@12 (2/17/2019), 09212018@15 (3/20/2019), and 11132018@1 (5/12/2019).
Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- Sermorelin 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
- Manufacturer
- Promise Pharmacy, LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 255
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 (4)
- Lots: 06182018@2 BUD: 12/15/2018
- 08212018@12 BUD: 2/17/2019
- 09212018@15 BUD: 3/20/2019
- 11132018@1 BUD: 5/12/2019
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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