CEREBROLYSIN — Class II drug recall D-0139-2021
Ongoing recall by Advanced Nutriceuticals, LLC, reported 2020-12-23, distributed in CA, CO, FL, IN, KY, OH, TX. Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of pro
| Recall number | D-0139-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advanced Nutriceuticals, LLC, Indianapolis, IN, United States |
| Recall initiated | 2020-11-30 |
| Classified | 2020-12-11 |
| Reported by FDA | 2020-12-23 |
| Distributed | CA, CO, FL, IN, KY, OH, TX |
| Quantity | 1 vials |
| Reason classes | sterility |
| Lot numbers | 1110202004 |
| Expiration dates | 2020-12-10 |
Product
CEREBROLYSIN, 107.5 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Reason for recall
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0139-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.