Agency classClass IIOur severity:Severe FDA (Drugs)·D-0451-2019·Announced 2019-02-20

Promise Pharmacy Recalls Sermorelin Injection Due to Sterility Concerns

Promise Pharmacy is recalling 296 vials of Sermorelin/GHRP2/GHRP6 injection due to a lack of sterility assurance. The product was 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving sterility issues in injectable drugs which carry significant risk.

Plain-English summary

Promise Pharmacy, LLC is recalling 296 vials of Sermorelin/GHRP2/GHRP6 6mg/3mg/3mg injection. The recall was initiated because of a lack of sterility assurance in the product. The affected lots are 08302018@13 with a best use date of 2/26/2019, and 09212018@14 with a best use date of 3/20/2019.

The product was 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 who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.

The recalled product

Product: Sermorelin/GHRP2/GHRP6 6mg/3mg/3mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Manufacturer: Promise Pharmacy, LLC
Category: Drug — Compounded Injectable
Hazard: sterility
infection
Affected units: 296

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 (2)

Lots: 08302018@13 BUD: 2/26/2019
09212018@14 BUD: 3/20/2019

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 →

Same manufacturer · Promise Pharmacy, LLC

See all →

Severe
MIC+Methyl B12 Injection Recalled for Lack of Processing Controls
FDA (Drugs) · 2021-09-22
Severe
Promise Pharmacy Recalls Lysine HCl Injection Due to Sterility Concerns
FDA (Drugs) · 2019-02-20
Severe
Promise Pharmacy Recalls Acetylcysteine Ophthalmic Solution Due to Sterility Concerns
FDA (Drugs) · 2019-02-20
Severe
Promise Pharmacy Recalls Sermorelin Injections Due to Sterility Concerns
FDA (Drugs) · 2019-02-20
Severe
Promise Pharmacy Recalls Epithalon Injections Due to Sterility Concerns
FDA (Drugs) · 2019-02-20

Same hazard · sterility