The Recall Desk
ModerateFDA (Drugs)·D-1725-2019·Announced 2019-08-21

US Pharmaceuticals Recalls Intensive Healing Eczema Lotion for Water Quality Issues

US Pharmaceuticals is recalling Intensive Healing Eczema Lotion due to out-of-specification results for microbial count or organic carbon in the purified water used during manufacturing.

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 manufacturing deviation (water quality) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

US Pharmaceuticals Inc. is recalling 533 cases of Intensive Healing Eczema (Hydrocortisone) Lotion, 3.5 oz, distributed by Walgreen Co. The affected product is identified by Lot #36P17 with an expiration date of 11/2019. The product was distributed nationwide in the USA.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the purified water utilized in the manufacturing process yielded out-of-specification results for either total microbial count or total organic carbon.

Consumers who have this specific lot of the product should stop using it and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
INTENSIVE HEALING ECZEMA (HYDROCORTISONE)
Brand
INTENSIVE HEALING ECZEMA
Affected units
533

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 #36P17 EXP 11/2019

UPCs (2)

  • 0311917193083
  • 311917193083

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 18 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.

See all 18 products in this recall →