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.
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 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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