Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Hydrocortisone Cream With Aloe
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
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
Affected NDC
0363-0620-03
Compare with the code on your package — it is the most precise check available.
Drug: Hydrocortisone
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Maximum Strength Hydrocortisone Cream with Aloe Hydrocortisone Cream NDC 00363-0620 |
HYDROCORTISONE 1 g/100g | Cream Topical |
Walgreens | OTC |
- Recalling firm
- US Pharmaceuticals Inc.
- NDC code
- 0363-0620-03
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1731-2019 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Hydrocortisone recalls
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Class II · Moderate risk
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CGMP Deviations; deficiencies observed during FDA inspection
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