Recalls / Class II
Class IID-0263-2025
Product
Chlorambucil Container Description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.
- Affected lot / code info
- Lot Numbers: HACUC0010722, exp. date Jun-2025 HACUC0010123, exp. date Dec-2025
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Aspen Biopharma Labs Pvt., Ltd.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Plot No 10, Biotech Park Phase-II, Lalgadi Malakpet Village,Turkapally, Shameerpet Mandal, Medchal Malkajgiri, N/A, India
Distribution
- Quantity
- 5.1 kg
- Distribution pattern
- Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in Florida)
Timeline
- Recall initiated
- 2025-02-07
- FDA classified
- 2025-03-09
- Posted by FDA
- 2025-03-19
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0263-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.