FDA-Drug2020-12-23Class II

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

BASF Corporation
Hazard

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

Sold states
USA Nationwide and Worldwide
Affected count
4560 kg
Manufactured in
100 Park Ave, N/A, Florham Park, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0149-2021

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