Innoveix Pharmaceuticals, Inc. is recalling certain sterile compounded drug products, within expiry, citing a lack of assurance of sterility, the U.S. Food and Drug Administration said.

The affected products are injectable Semorelin / Ipamorelin 3mg and injectable AOD-9604 3mg. The products can be used for various indications as prescribed.

Semorelin / Ipamorelin 3mg recall includes Lot# SIP210 with Exp: 12/15/2021; Lot# SIP215 with Exp: 01/14/2022; and Lot# SIP220 with Exp: 01/23/2022.

Further, AOD-9604 3mg recall includes Lot# AOD205 with Exp: 11/09/2021; Lot# AOD210 with Exp: 11/18/2021; Lot# AOD 215 with Exp: 12/15/2021; and Lot# AOD202 with Exp: 11/09/2021.

The affected products can be identified by an Innoveix Pharma label. They were distributed in glass vials contained in a small 3 inch by 3 inch white box. Products were distributed across the United States to both customers and/or medical facilities.

The recall was initiated after concerns arose following a routine inspection of the pharmacy by FDA.

According to the agency, administration of a drug product intended to be sterile, that is not sterile, could result in serious infections which may be life-threatening.

However, the company has not received any reports of adverse events related to this recall to date.

Customers who have received sterile compounded products subject to the recall are urged to return the product to the pharmacy for a full refund.

For comments and feedback contact:

Business News

Source link