Drug 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
D-0486-2019
Product summary
- Firm
- LGM Pharma LLC
- Event
- Event 81790
- Status
- Terminated
- Classification
- Class II
- Quantity
- 205 grams
- Official record key
drug-enforcement:D-0486-2019
Official wording
Reason: CGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Code information: Lot number: JD-BP-37-20150801
Distribution pattern: Distributed to MS and Spain
Derived failure modes
-
Manufacturing or process control
CGMP Deviations