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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86805

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

Open FDA event record

Event summary

Timeline bucket
November 17, 2020
Product types
Drug
Classifications
Class II
Statuses
Completed
Recalling firm wording
BASF Corporation

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

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

Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized, packaged in 30 kg plastic drums, Manufacturer: BASF SE, Carl-Bosch-Strabe 38, 67056 Ludwigshafen, Germany, Co-Manufactured by Siegfried PharmaChemikalien Minden GmbH, D-32423 Minden

D-0149-2021
Recall number
D-0149-2021
Initiated
November 17, 2020
Classification
Class II
Status
Completed
Recalling firm
BASF Corporation
Quantity
4560 kg

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cross contamination: the excipient was found to be contaminated with theophylline.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Cross contamination: the excipient was found to be contaminated with theophylline.

Code information

Batch # 18472036, 18472041.

Distribution pattern

USA Nationwide and Worldwide