August 2017 FDA Recall Drug by Medline Industries Inc
D-1138-2017 - 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.

This Class II drug recall was voluntarily initiated by Medline Industries Inc on August 3, 2017 for the product Drug. The FDA reported the reason for recall as 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.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1138-2017

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.
Initiated
08-03-2017
Reported
09-20-2017
Quantity
462 cases, 144 packets per case

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77936
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
MEDLINE INDUSTRIES INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-21-2017
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot Number: A-K-8383