FDA recall D-0630-2017

Product

Nifedipine Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-369-01.

Reason for recall

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2017-03-07

Report date

2017-04-12

Termination date

2017-12-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pine Brook, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0630-2017