CLASS II Drug recall · Reported 20 Feb 2019 · FDA Enforcement Report
Cidofovir Dihydrate, (Non-Sterile, For Manufacturing Use) recalled
LGM Pharma is recalling Cidofovir Dihydrate, (Non-Sterile, For Manufacturing Use), distributed in Mississippi. The recall was initiated on 18 Dec 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0486-2019
- FDA event ID
- 81790
- Recalling firm
- LGM Pharma, Erlanger, KY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Dec 2018
- FDA classified
- 11 Feb 2019
- Reported
- 20 Feb 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 18 Dec 2018 | Recall initiated by company | |
| 11 Feb 2019 | Classified by FDA | +55 days |
| 20 Feb 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Product as listed by the FDA
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
Where it was distributed
Distributed to MS and Spain
Questions about this recall
Why was it recalled?
CGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Which lots are affected?
Lot number: JD-BP-37-20150801
Where was it sold?
Distributed to MS and Spain
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from LGM Pharma
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Thyroid Powder, USP/drum recalled by LGM Pharma | LGM Pharma | Manufacturing (CGMP) Deviations | Nationwide |