CLASS II Drug recall · Reported 20 Sep 2017 · FDA Enforcement Report

Vitamin A&D Ointment (petroleum 93.5%), Skin Protectant recalled

Medline Industries is recalling Vitamin A&D Ointment (petroleum 93.5%), Skin Protectant, distributed nationwide in the US. The recall was initiated on 3 Aug 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: A-K-8383
Quantity recalled462 cases, 144 packets per case

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-1138-2017
FDA event ID
77936
Recalling firm
Medline Industries, Northfield, IL
Classification
Class II
Status
Terminated
Recall initiated
3 Aug 2017
FDA classified
12 Sep 2017
Reported
20 Sep 2017
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Labeling Errors

Timeline

3 Aug 2017Recall initiated by company
12 Sep 2017Classified by FDA+40 days
20 Sep 2017Published in enforcement report+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

Nationwide

Nationwide

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

Lot Number: A-K-8383

Where was it sold?

Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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