FDA-Drug2020-10-07Class II
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
SUN PHARMACEUTICAL INDUSTRIES INC
Hazard
CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
Sold states
Nationwide
Affected count
747 bottles
Manufactured in
2 Independence Way, N/A, Princeton, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0002-2021Don't want to check this manually?
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