Medline Recalls Mislabelled Vitamin A&D Ointment Packets
Medline Industries is recalling Vitamin A&D Ointment packets that are incorrectly labeled as petroleum jelly. The outer boxes are correctly labeled.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a minor labeling error where the product is misidentified as petroleum jelly, which aligns with the rubric for moderate severity.
Plain-English summary
Medline Industries, Inc. is recalling 462 cases of Vitamin A&D Ointment (petroleum 93.5%), Skin Protectant, NET Wt. 0.18 OZ (5g). The product is manufactured for Medline Industries, Inc., located in Northfield, IL, and carries the NDC 53329-090-16. The recall involves Lot Number A-K-8383, with 144 packets per case.
The recall was initiated due to a labeling mixup where the individual foil packets are incorrectly labeled as petroleum jelly. However, the boxes and outer cases are correctly labeled as A&D ointment. The product was distributed nationwide.
Consumers who have purchased this specific lot should check their packaging. If the individual foil packets are labeled as petroleum jelly, they should stop using the product and contact Medline Industries for further instructions.
The recalled product
- 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
- Manufacturer
- MEDLINE INDUSTRIES INC
- Category
- Drug — Topical Ointment
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: A-K-8383
Distribution
Distributed nationwide across the United States.
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