The Recall Desk
HighFDA (Drugs)·D-0456-2019·Announced 2019-02-20

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.

What this means for you

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
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 →