Sermorelin Acetate 9 mg. Compounded by Tri-Coast Pharmacy

FDA Recall #D-0288-2017 — Class II — November 17, 2016

Recall #D-0288-2017 Date: November 17, 2016 Classification: Class II Status: Ongoing

Product Description

Sermorelin Acetate 9 mg. Compounded by Tri-Coast Pharmacy

Reason for Recall

Lack of Assurance of Sterility

Recalling Firm

Tri-Coast Pharmacy — Juno Beach, FL

Classification

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

Product Type

Drugs

Product Quantity

54 vials

Distribution

Nationwide

Code Information

Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 08022016B (01/29/2017).

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated