FDA recall D-1364-2020

Product

Metformin HCl Extended Release Tablets, USP, 500 mg, Generic for Glucophage XR, Pkg Size 100, Mfg: Time-Cap, Labs Inc., Farmingdale, NY, Preferred Pharmaceuticals, Anaheim, CA NDC: 68788-6932-01

Reason for recall

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.

Distribution

Product was distributed to two medical clinics located in FL.

Key facts

Status

Terminated

Initiation date

2020-06-17

Report date

2020-07-08

Termination date

2024-03-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Anaheim, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1364-2020