SUN PHARMACEUTICAL INDUSTRIES INC recalls RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL 16 oz. For Oral Use Only Rx On
Recalled October 7, 2020 · FDA recall D-0002-2021 · SUN PHARMACEUTICAL INDUSTRIES
Hazard
CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product. · FDA Class II
Units
747 bottles
Sold at
Nationwide
Description
CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
Product
RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL 16 oz. For Oral Use Only Rx Only Manufactured by: Sun Pharmaceuticals Industries Limited Mohali, India Distributed by: Sun Pharmaceuticals Industries, Inc. Cranbury, NJ 08512 NDC 10631-019-17
Manufacturer(s)
SUN PHARMACEUTICAL INDUSTRIES INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →