FDA recall D-0056-2021

Product

Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackaged By: Northwind Pharmaceuticals North Blenheim NY 12131 NDC 70934-334-30

Reason for recall

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

Distribution

Indiana - Nationwide.

Key facts

Status

Ongoing

Initiation date

2020-10-08

Report date

2020-11-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Blenheim, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0056-2021