FDA recall D-1138-2017

MEDLINE INDUSTRIES INC · Class II · drug

Product

Vitamin A&D Ointment (petroleum 93.5%), Skin Protectant, NET Wt. 0.18 OZ (5g), Manufactured for Medline Industries, Inc., Northfield, IL 60093 USA. NDC: 53329-090-16

Reason for recall

Labeling Mixup; the individual A&D ointment foil packets are incorrectly labeled as petroleum jelly. The boxes and outer case are correctly labeled as A&D ointment.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2017-08-03
Report date
2017-09-20
Termination date
2017-11-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1138-2017