FDAClass IIAugust 21, 2019

Eczema recall: CGMP Deviations

Eczema Lotion Hydrocortisone 1% / Anti-Itch Lotion, 3.5 oz (99.2 g) Distributed By: Walgreen Co. 200 Wilmot Rd. Deerfield, IL,60015. NDC 0363-0670-04, UPC 3 11917 19308 3

Why was Eczema recalled?

CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #36P17 EXP 11/2019

Product
Eczema Lotion Hydrocortisone 1% / Anti-Itch Lotion, 3.5 oz (99.2 g) Distributed By: Walgreen Co. 200 Wilmot Rd. Deerfield, IL,60015. NDC 0363-0670-04, UPC 3 11917 19308 3
Recalling firm
US Pharmaceuticals Inc.
Quantity
533 cases
Distribution
Distributed Nationwide in the USA
Recall date
August 21, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls