Promise Pharmacy Recalls Leucine/Isoleucine/Valine Injection Due to Sterility Concerns
Promise Pharmacy, LLC is recalling Leucine/Isoleucine/Valine injection vials due to a lack of sterility assurance. The affected products 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 FDA classified this recall as Class II. According to the severity rubric, an FDA Class II recall involving a significant hazard such as lack of sterility assurance in an injectable product is categorized as Severe (Score 4).
Plain-English summary
Promise Pharmacy, LLC is recalling 15 10mL vials of Leucine/Isoleucine/Valine injection, 10mg/10mg/5mg/mL/mL. The recall is being conducted due to a lack of sterility assurance. The affected product is identified by Lot 10312018@3 with a beyond-use date of 12/15/2018.
The recalled products were distributed nationwide in the United States. 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 or where the probability of serious adverse health consequences is remote.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for further instructions on disposal or replacement.
The recalled product
- Product
- Leucine/Isoleucine/Valine injection, 10mg/10mg/5mg/mL/mL, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
- Manufacturer
- Promise Pharmacy, LLC
- 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)
- Lot: 10312018@3 BUD: 12/15/2018
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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