Promise Pharmacy Recalls IGF-1 LR3 Injections Due to Sterility Concerns
Promise Pharmacy is recalling 59 vials of IGF-1 LR3 injections because they lack sterility assurance. The affected products were distributed nationwide.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (injection lacking sterility assurance) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Promise Pharmacy, LLC is recalling 59 vials of IGF-1 LR3, 620 mcg injection, Rx Only. The recall is being conducted because the product lacks sterility assurance. The affected lot is 06282018@3 with a beyond-use date of 12/25/2018.
The recalled products were distributed nationwide in the USA. The source text does not specify the number of patients affected or report any illnesses or injuries associated with the use of these products.
Consumers who have this specific product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- IGF-1 LR3, 620 mcg 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
- 59
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: 06282018@3 BUD: 12/25/2018
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.
See all 51 products in this recall →Related recalls
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