FDAClass IIJuly 28, 2021

Compounded Lyophilized Semorelin/Ipamorelin 3 mg For recall: Sterility Concern

Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001…

Why was Compounded Lyophilized Semorelin/Ipamorelin 3 mg For recalled?

Lack of Assurance of Sterility

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: SIP215 Exp. 01/14/2022, SIP220 Exp. 01/23/2022, SIP210 Exp. 12/15/2021

Product
Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001…
Recalling firm
Innoveix Pharmaceuticals Inc
Quantity
728 vials
Distribution
Nationwide within the United States
Recall date
July 28, 2021
Classification
Class II
Status
Completed
Agency
FDA (drug)
Open FDA enforcement record Latest recalls