CIDOFOVIR DIHYDRATE — Class II drug recall D-0486-2019
Terminated recall by LGM Pharma LLC, reported 2019-02-20. CGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
| Recall number | D-0486-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LGM Pharma LLC, Erlanger, KY, United States |
| Recall initiated | 2018-12-18 |
| Classified | 2019-02-11 |
| Reported by FDA | 2019-02-20 |
| Terminated | 2023-06-09 |
| Countries outside the US | ES |
| Quantity | 205 grams |
| Reason classes | cgmp |
| Lot numbers | JD-BP-37-20150801 |
Product
CIDOFOVIR DIHYDRATE, (Non-Sterile, For Manufacturing Use), 10g, Rx only, ALP PHARM BEIJING CO., LTD, 12-2-620, Jia 69, Fushi Rd., Haidian, Beijing 100049, China. Batch Number JD-BP-37-20150801
Reason for recall
CGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
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-0486-2019. 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.