Class II · Moderate risk
Voriconazole Tablets
cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.
Voriconazole Container Description: voriconazole The product…
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
Voriconazole Container Description: voriconazole The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping.
Drug: Voriconazole
- Recalling firm
- Aspen Biopharma Labs Pvt., Ltd.
- Origin
- India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0265-2025 · 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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Voriconazole for Oral Suspension
Labeling: Incorrect or Missing Package Insert
Class II · Moderate risk
Voriconazole 10mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
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Alprostadil Container Description: Amber color bottle
CGMP Deviations
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