Product: 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
Reason for recall: Cross contamination: the excipient was found to be contaminated with theophylline.
Recall initiated: 20201117
Status: Completed
Classification: Class II
Recall type: Voluntary: Firm initiated