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
D-1138-2017
Product summary
- Event
- Event 77936
- Status
- Terminated
- Classification
- Class II
- Quantity
- 462 cases, 144 packets per case
- Official record key
drug-enforcement:D-1138-2017
Official wording
Reason: 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.
Code information: Lot Number: A-K-8383
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling Mixup