US Pharmaceuticals Recalls Hydrocortisone Cream Due to Microbial Contamination
US Pharmaceuticals is recalling Hydrocortisone Cream Intensive Healing 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 and involves a low-risk contamination (microbial count in excipient) without reported illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
US Pharmaceuticals Inc. is recalling Hydrocortisone Cream Intensive Healing (Hydrocortisone Cream 1%) 2 oz tubes, distributed by Walgreen Co. The recall involves 67,848 units distributed nationwide within the United States.
The recall was initiated due to Good Manufacturing Practice (GMP) deviations, specifically out-of-specification results for Total Aerobic Microbial count in an excipient purified water sample. The affected lots are 36G17 and 47G17 (Expiration 5/2019) and 84J17 (Expiration 7/2019).
Consumers with these products should stop using them and return them to the point of purchase or contact the manufacturer for instructions.
The recalled product
- Product
- HYDROCORTISONE CREAM INTENSIVE HEALING (HYDROCORTISONE CREAM)
- Brand
- HYDROCORTISONE CREAM INTENSIVE HEALING
- Manufacturer
- US Pharmaceuticals Inc.
- Category
- Drug — Topical Corticosteroid
- Hazard
- Affected units
- 67,848
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 (5)
- Lot #: 36G17
- 47G17
- Exp. 5/2019
- 84J17
- Exp. 7/2019
UPCs (1)
- 0311917187297
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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