FDA recall D-0568-2016

National Vitamin Co Inc · Class III · drug

Product

Life-Line DOCUSATE CALCIUM Sodium Free STOOL SOFTENER 240 mg each, 100 softgels per bottle. UPC 0-79854-95005-2 Manufactured and Distributed by: NATIONAL VITAMIN COMPANY Casa Grande, AZ 85122. NDC 54629-0640-01

Reason for recall

Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2015-12-18
Report date: 2016-01-20
Termination date: 2016-05-03
Voluntary/Mandated: Voluntary: Firm initiated
Location: Casa Grande, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0568-2016