Sermorelin, 3 mg/ GHRP6, 3 mg/GHRP2, 3 mg, Vial - Lyophilized, For SC Use, Rx Only, KRS Global Bi...

FDA Recall #D-0195-2018 — Class II — November 16, 2017

Recall #D-0195-2018 Date: November 16, 2017 Classification: Class II Status: Terminated

Product Description

Sermorelin, 3 mg/ GHRP6, 3 mg/GHRP2, 3 mg, Vial - Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.

Reason for Recall

Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

Recalling Firm

KRS Global Biotechnology, Inc — Boca Raton, FL

Classification

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

Product Type

Drugs

Product Quantity

597 vials

Distribution

Nationwide in the USA, Bermuda, and New Zealand

Code Information

Lots: 06162017@12 BUD: 12/13/2017; 08042017@1 BUD: 1/31/2018

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated