The Recall Desk
SevereFDA (Drugs)·D-0448-2019·Announced 2019-02-20

Promise Pharmacy Recalls Sermorelin Theanine/GHRP2 Injection Due to Sterility Concerns

Promise Pharmacy is recalling Sermorelin Theanine/GHRP2 injections due to a lack of sterility assurance. The affected lot was 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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated Severe. Lack of sterility assurance in an injectable drug poses a significant risk of serious injury (infection/sepsis), fitting the Severe criteria for high-risk medical products.

Plain-English summary

Promise Pharmacy, LLC is recalling Sermorelin Theanine/GHRP2, 15 mg/75 mg/5.4 mg injection, Rx Only. The recall is being conducted due to a lack of sterility assurance in the product.

The affected product consists of 25 vials per lot. The specific lot number is 07202018@4, with a beyond-use date of 1/16/2019. The product was distributed nationwide in the USA.

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
Sermorelin Theanine/GHRP2, 15 mg/75 mg/5.4 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Affected units
25

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: 07202018@4 BUD: 1/16/2019

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.

See all 51 products in this recall →