FDA recall D-0002-2021

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

Reason for recall

CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2020-09-23

Report date

2020-10-07

Termination date

2021-11-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0002-2021