BASF Corporation recalls Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized, packaged in 30 kg plastic drums, Manufacturer: BASF S…

Recall date

November 17, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0149-2021

FDA classification

Class II

Brand / firm

BASF Corporation

Sold / distributed

USA Nationwide and Worldwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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