Class II · Moderate risk
Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant
cGMP deviations
Wecare Calasoothe (Menthol and Zinc Oxide)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP deviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Wecare Calasoothe, Net wt. 4 oz (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, NDC 67777-234-04.
Affected NDC
67777-0234-04
Compare with the code on your package — it is the most precise check available.
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 |
|---|---|---|---|---|
| Menthol and Zinc Oxide NDC 67777-0234 |
MENTHOL .44 g/100g; ZINC OXIDE 21 g/100g | Ointment Topical |
Dynarex Corporation | OTC |
- Recalling firm
- Blossom Pharmaceuticals
- NDC code
- 67777-234-04
- Origin
- India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0213-2026 · 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.
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