Sermorelin Theanine/GHRP2, 15 mg/75 mg/5.4 mg injection, Rx Only, Promise Pharmacy Compounding Sp...

FDA Recall #D-0448-2019 — Class II — December 17, 2018

Recall #D-0448-2019 Date: December 17, 2018 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

Lack of sterility assurance.

Recalling Firm

Promise Pharmacy, LLC — Palm Harbor, FL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

25 vials

Distribution

Nationwide in the USA.

Code Information

Lot: 07202018@4 BUD: 1/16/2019

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated