STRONTIUM CHLORIDE Sr-89 (Page 3 of 3)

HOW SUPPLIED/STORAGE AND HANDLING

STRONTIUM CHLORIDE Sr-89 INJECTION, USP is supplied in a 5 mL vial containing 148 MBq, 4 mCi. The vial is shipped in a transportation shield-container with a package insert, and two therapeutic agent-warning labels.

The vial and its contents should be stored inside its transportation container at room temperature (15-25°C, 59-77°F).

The calibration date and expiration date are quoted on the vial label. Do not use after the expiration date. Stability studies have shown no change in any of the product characteristics monitored during routine product quality control over the period from manufacture to expiration.

This radiopharmaceutical is licensed by the Texas Department of Health, or under equivalent licesnses of the U.S. Nuclear Regulatory Comminssion or an agreement state.

NDC72928-089-01

PRODUCT INFORMATION ISSUED: January 20, 2020

Manufactured for:
Q BioMed, Inc.
366 Madison Ave, Third Floor
New York, NY 10017

Manufactured by:
Isotherapeutics Group LLC
1004 S. Velasco St.
Angleton, Texas (TX) 77515

Printed in U.S.A.
L-089-11I
Product Code: P089-0

Drug Product Label

Vial Label

Outer Container Label

STRONTIUM CHLORIDE SR-89 strontium chloride sr-89 injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72928-089 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STRONTIUM CHLORIDE SR-89 (STRONTIUM CATION SR-89) STRONTIUM CATION SR-89 1 mCi in 1 mL

Inactive Ingredients Ingredient Name Strength water

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:72928-089-01 5 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075941 01/06/2003

Labeler — Q BioMed Inc (055083004)

Registrant — Q BioMed Inc (055083004)

Establishment
Name	Address	ID/FEI	Operations
IsoTherapeutics Group LLC		621139976	MANUFACTURE (72928-089)

Establishment
Name	Address	ID/FEI	Operations
Narodowe Centrum Badan Jadrowych (dba Polatom)		422187116	api manufacture (72928-089)

Revised: 10/2022 Q BioMed Inc