Class II · Moderate risk
Voriconazole Container Description: voriconazole The product…
CGMP Deviations
Chlorambucil Container Description: The product packed in double…
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
Chlorambucil Container Description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.
- Recalling firm
- Aspen Biopharma Labs Pvt., Ltd.
- Origin
- India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0263-2025 · 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.
Other recalls by Aspen Biopharma Labs Pvt., Ltd.
All 2025 recalls
Class II · Moderate risk
Class II · Moderate risk
Class II · Moderate risk
Alprostadil Container Description: Amber color bottle
CGMP Deviations
Other cgmp deviation recalls from 2025
All cgmp deviation recalls
Class II · Moderate risk
TPN bag (patient specific)
Incorrect Product Formulation: product did not contain insulin as listed in the label.
Class II · Moderate risk
Toothpaste: a) COLGATE
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk
Deodorant: a) Axe
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk
Petroleum jelly: a) Vaseline Petroleum Jelly
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
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