Medline Remedy Barrier Ointment Recalled for Microbial Contamination
US Pharmaceuticals is recalling Medline Remedy Barrier Skin Protectant Ointment due to out-of-specification microbial counts in purified water.
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, which typically indicates a temporary or medically reversible adverse health consequence. The hazard is a GMP deviation involving microbial counts in an excipient, which is a low-risk contamination issue without reported illnesses.
Plain-English summary
US Pharmaceuticals Inc. is recalling Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) in 2 oz and 6 oz tubes. The recall affects 7,020 units of Lot # 44G17, which expired in May 2019. The product was distributed nationwide within the United States.
The recall was initiated due to Good Manufacturing Practice (GMP) deviations. Specifically, out-of-specification results were found for the Total Aerobic Microbial count in a purified water excipient sample used in the product.
Consumers who have this product should stop using it and contact US Pharmaceuticals Inc. for further instructions or a refund. The product is identified by NDC 53329-302-14 (2 oz) and NDC 53329-302-41 (6 oz).
The recalled product
- Product
- Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) packaged in a) 2 oz tubes (NDC 53329-302-14) and b) 6 oz tubes (NDC 53329-302-41), Medline Industries Inc., Manufactured for Medline Industries Inc., Mundelien, IL 60060.
- Manufacturer
- US Pharmaceuticals Inc.
- Category
- Drug — Topical Ointment
- Affected units
- 7,020
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 (2)
- Lot # a) and b): 44G17
- Exp. 05/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by US Pharmaceuticals Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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