Class II · Moderate risk
Inhub Wixela
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Folic Acid Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
What was recalled
FOLIC ACID TABLETS, USP, 1MG, 100 Tablets per bottle, Rx Only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004. NDC: 69315-127-10
Affected NDC
69315-0127-10
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 |
|---|---|---|---|---|
| Folic Acid NDC 69315-0127 |
1 mg/1 | Tablet Oral |
Leading Pharma, LLC | Rx |
- Recalling firm
- Cardinal Healthcare
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0183-2024 · 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 recalls by Cardinal Healthcare
All 2022 recalls
Class II · Moderate risk
Warfarin Sodium Tablets
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
Warfarin Sodium Tablets
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
Triamterene and Hydrochlorothiazide Capsules
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Other temperature excursion recalls from 2022
All temperature excursion recalls
Class II · Moderate risk
Colgate Whitening Mouthwash
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Class II · Moderate risk
Colgate Anticavity Fluoride Toothpaste OPTIC WHITE STAIN FIGHTER…
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Class II · Moderate risk
Colgate Anticavity Fluoride Toothpaste
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Class II · Moderate risk
Colgate Anticavity Fluoride Toothpaste
cGMP deviation: Product held outside of appropriate temperature storage conditions.
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