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.
What this means for you
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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