LGM Pharma Recalls Cidofovir Dihydrate Due to CGMP Deviations
LGM Pharma LLC is recalling Cidofovir Dihydrate because the API manufacturer is on FDA Import Alert for CGMP deviations.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a temporary or medically reversible adverse health consequence. The source text does not report any specific illnesses, injuries, or deaths, and the hazard is related to manufacturing compliance (CGMP deviations) rather than a confirmed high-risk pathogen or structural defect.
Plain-English summary
LGM Pharma LLC is recalling Cidofovir Dihydrate, a prescription-only active pharmaceutical ingredient (API) used for manufacturing. The product is in 10g units, with a total quantity of 205 grams involved in this recall. The specific lot number is JD-BP-37-20150801.
The recall was initiated because the API manufacturer, ALP PHARM BEIJING CO., LTD, is on FDA Import Alert for Current Good Manufacturing Practice (CGMP) deviations. The product was distributed to Mississippi and Spain.
Consumers and healthcare providers should stop using the affected product and contact LGM Pharma LLC for further instructions or a refund.
The recalled product
- 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
- Manufacturer
- LGM Pharma LLC
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot number: JD-BP-37-20150801
Distribution
Distributed in 1 state:
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