FDA recall D-0785-2016

Safecor Health, LLC · Class II · drug

Product

Phenobarbital/Hyoscyamine/ Atropine/Scopolamine 16.2/0.1037/0.0194/0.0065 mg DONNATAL ELIXIR, 5 ml Cup grape, Alcohol 23.8%, Rx Only, MFG: Concordia, PKG BY: SAFECOR HEALTH, WOBURN, MA, C5921242304.

Reason for recall

Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml.

Distribution

Key facts

Status: Terminated
Initiation date: 2015-07-16
Report date: 2016-04-06
Termination date: 2016-03-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Woburn, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0785-2016