FDA recall D-0628-2017

Product

Adalat CC (nifedipine) Extended Release Tablets 30 mg, 100-count bottles, Rx only, Manufactured for Bayer Healthcare Bayer Healthcare Pharmaceuticals Inc. Whippany, NJ 07901 Manufactured in Germany, NDC 50419-701-05

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-0628-2017