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FDAFDA · Food and drugs·Recall number D-0149-2021

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

Published December 23, 2020 · Recall initiated: November 17, 2020

Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recall details

Manufacturer
BASF Corporation
Distributor
USA Nationwide and Worldwide
Lot
Batch # 18472036, 18472041.
Risk classification
Class II
Area (FDA)
drug
Country
United States

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