The Recall Desk
SevereFDA (Drugs)·D-0464-2019·Announced 2019-02-20

Promise Pharmacy Recalls IGF-1-LR3 Injections Due to Sterility Concerns

Promise Pharmacy, LLC is recalling 59 vials of IGF-1-LR3, 3 mg injection due to a lack of sterility assurance. The product was distributed nationwide in the USA.

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 significant risk of serious injury or infection.

Plain-English summary

Promise Pharmacy, LLC is recalling 59 vials of IGF-1-LR3, 3 mg injection, Rx Only. The recall was initiated because of a lack of sterility assurance in the product. The affected lot is 06282018@2 with a beyond-use date of 12/25/2018.

The product was distributed nationwide in the USA. The recall is classified as Class II by the U.S. Food and Drug Administration.

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
IGF-1-LR3, 3 mg 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@2 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 →