Hydrocortisone Cream With Aloe recalled over manufacturing violations
- Recall date
- July 11, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- US Pharmaceuticals Inc. recalls Hydrocortisone Cream With Aloe, Hydrocortisone 1% / Anti-Itch Cream with Aloe, 1 OZ (28 g) tube. Distributed By: Walgre…
- Recall number
- D-1731-2019
- FDA classification
- Class II
- Brand / firm
- US Pharmaceuticals Inc.
- Sold / distributed
- Distributed Nationwide in the USA
Why it was 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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Hydrocortisone Cream With Aloe, Hydrocortisone 1% / Anti-Itch Cream with Aloe, 1 OZ (28 g) tube. Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC #0363-0620-03, UPC 3 11917 17935 3
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