Sun Pharmaceutical Industries Inc. Issues Voluntary Nationwide Recall of Riomet®

Sun Pharmaceutical Industries Ltd. SUN HOUSE, CTS No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063, India Tel.: (91-22) 4324 4324 Fax.: (91-22) 4324 4343 CIN: L24230GJ1993PLC019050 www.sunpharma.com Registered Office : SPARC, Tandalja, Vadodara – 390 020. India FOR IMMEDIATE RELEASE Sun Pharmaceutical Industries Inc. Issues Voluntary Nationwide Recall of Riomet® (Metformin Hydrochloride Oral Solution) Manufactured by a Contract Manufacturer due to Microbial Contamination Mumbai, India & Cranbury, New Jersey, November 24, 2017 – Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Indus tries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NS E: SUNPHARMA, BSE: 524715, “Sun Pharma” including its subsidiaries and/or associate companies) is volunta rily recalling two lots of Riomet ® (Metformin Hydrochloride Oral Solution), 500 mg/5m L, to the retail level (Class II Recall). This product is manufactured for SPII by a contract manufacturer. The Riomet ® (Metformin Hydrochloride Oral Solution) has been found to be contaminated (Scopulariopsis brevicaulis) . The contamination was discovered during sample preparation for the Antimicrobial Preservative Effectiveness Testing (AMPET) being performed as part of the 12 month stability study interval. Use of Riomet ® (Metformin Hydrochloride Oral Solution) potentiall y could result in a risk of infection, especially i n the immunocompromised patient. The most plausible portal of entry of Scopulariopsis brevicaulis is the respiratory tract, where it may cause pneumonia, sinusitis and disseminated infections. To date, SPII has not rece ived any reports of adverse events related to this recall. Riomet ® (Metformin Hydrochloride Oral Solution) is indicated to treat type 2 diabetes mellitus in adult and children age 10 and above. Riomet is packaged in 118 mL (4 fl. oz.) and 473 mL (16 fl. oz.) bottles. The affected Riomet ® (Metformin Hydrochloride Oral Solution) includes pr oduct with NDC Code 10631-206-01 Lot A160031A, Exp. : 01/2018, and NDC 10631-206-02 Lot: A160031B, Exp.: 01/2018. The product can be identified by its bottle labeled as Riomet ® (Metformin Hydrochloride Oral Solution) containing the specific Lot and Exp. dates mentioned above. This product was distributed nationwide to wholesale customers. Photos for 16 oz. bottle for reference: On April 18, 2017, SPII notified its wholesale cust omers through its 3rd party Recall Coordinator (Inm ar Inc.) via FedEx standard overnight shipping and has arranged for the return via prepaid FedEx Ground shipping of all recalled products. Consumers that have Riomet ® (Metformin Hydrochloride Oral Solution) which has been recalled should stop using and return it to place of purchase, discard and/or contact their doctor. Sun Pharmaceutical Industries Ltd. SUN HOUSE, CTS No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063, India Tel.: (91-22) 4324 4324 Fax.: (91-22) 4324 4343 CIN: L24230GJ1993PLC019050 www.sunpharma.com Registered Office : SPARC, Tandalja, Vadodara – 390 020. India Consumers with questions regarding this recall can contact SPII by calling 1-800-406-7984, Monday through Friday between 8:00 am to 5:00 pm EST or emailing drug.saf [email protected]. Consumers should contact thei r physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced w ith the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. • Complete and submit the report Online: www.fda.gov/medwatch/report.htm • Regular Mail or Fax: Download form www.fda.gov/MedW atch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. ® - All brand names and trademarks are the property of respective owners. Disclaimer: Statements in this “Document” describing the Compan y’s objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be “forward looking statements” within the meaning of applicable securities laws and regulations. Actual results, pe rformance or achievements could differ materially f rom those expressed or implied. About Sun Pharmaceutical Industries Ltd. (CIN - L24230GJ1993PLC019050): Sun Pharma is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company. A vertically integrated business, economies of scale and an extremely skilled team enable us to deliver quality products in a timely manner at affordable prices. It provides high-quality, affordable medicines trusted by customers and patients in over 150 countries across the world. Sun Pharma's global presence is s upported by 41 manufacturing facilities spread acro ss 6 continents, R&D centres across the globe and a multi-cultural workforce comprising over 50 nationalities. In India, the company enjoys leadership across 11 different classes of doctors with 30 bran ds featuring amongst top 300 pharmaceutical brands in India. Its footprint across emerging markets covers over 100 markets and 6 markets in Western Europe. Its Global Consumer Healthcare business is ranked amongst Top 10 across 3 global markets. I ts API business footprint is strengthened through 1 4 world class API manufacturing facilities across the globe. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities comprising about 2,000 scientists and R&D investments of approximately 8% of annual revenues. For further information please visit www.sunpharma.com & follow us on Twitter @SunPharma_Live Contacts: Investors: Media: Nimish Desai Gaurav Chugh Tel +91 22 4324 4324, Xtn 2778 Tel +91 22 4324 432 4, Xtn 5373 Tel Direct +91 22 4324 2778 Tel Direct +91 22 4324 5373 Mobile +91-98203 30182 Mobile +91 98104 71414 E mail [email protected] E mail gaurav.ch [email protected]

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