FDA recall D-0635-2017

Alvogen, Inc · Class III · drug

Product

Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749601

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-0635-2017