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Drug FDA Class II Ongoing cGMP deviation

Chlorambucil Container Description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.

Aspen Biopharma Labs Pvt., Ltd. Published Mar 19, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 50/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Aspen Biopharma Labs Pvt., Ltd. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

CGMP Deviations

Affected products (1)

Chlorambucil Container Description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.

5.1 kg

Lot codes: Numbers
Code info: Lot Numbers: HACUC0010722, exp. date Jun-2025 HACUC0010123, exp. date Dec-2025

Affected areas

Florida

Timeline

  1. Initiated
    Feb 7, 2025
  2. Published
    Mar 19, 2025
Recall number
D-0263-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.