Metformin Hydrochloride Tablets, USP

SECTION 2: Hazards identification

1272/2008 GLOBAL HARMONIZATION AND EU CLP REGULATION (EC) 1272/2008 LABELING AND

2.1 Classification of the substance or mixture

According to Article 1, item 5 (a) of CLP Regulation (EC) 1272/2008, medicinal products in the finished state for human use, as defined in 2001/83/EC, are excepted from classification and other criteria of 1272/2008. EU LABELING/CLASSIFICATION: According to Article 1 of European Union Council Directive 92/32/EEC, medical products in the finished state for human use (as defined by European Union Council Directives 67/548/EEC and 87/21/EEC) are not subject to the regulations and administrative provisions of European Union Council Directive 92/32/EEC. See Section 16 for full classification information of product and components. EMERGENCY OVERVIEW

Product definition

This product consists of oval-shaped white to off-white or brick red mottled tablets. Health Hazards: In the workplace, exposure to dusts of damaged tablets may cause irritation to skin, eyes and respiratory system. Non-therapeutic ingestion may be harmful. In therapeutic use, the most common adverse effects have included diarrhea, nausea, vomiting, abdominal bloating, abdominal cramping or pain, flatulence, infection and anorexia. Rarely, lactic acidosis can occur, which is a serious metabolic adverse effect. These effects may be possible as a result of workplace exposure. Refer to Section 11 (Toxicological Information) for additional information on adverse effects. Flammability This product is combustible and can ignite if highly heated or if exposed to direct flame. When involved in a fire, this material may decompose and produce irritating vapors and toxic compounds (including calcium, carbon, iron, titanium and nitrogen oxides and hydrogen chloride). Reactivity This product is not reactive.

Environmental hazards

May cause harm to aquatic organisms if accidentally released. All environmental release should be avoided. Emergency Recommendations: Emergency responders must wear personal protective equipment suitable for the situation to which they are responding.