Exact FDA event identifier

Event 81790

1 recalled-product record grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: December 18, 2018
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: LGM Pharma LLC

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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

Recall number: D-0486-2019
Initiated: December 18, 2018
Classification: Class II
Status: Terminated
Recalling firm: LGM Pharma LLC
Quantity: 205 grams

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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