PlainRecalls
FDA Drug Moderate Class II Completed

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

Reported: December 23, 2020 Initiated: November 17, 2020 #D-0149-2021

Product Description

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.

Details

Recalling Firm
BASF Corporation
Units Affected
4560 kg
Distribution
USA Nationwide and Worldwide
Location
Florham Park, NJ

Frequently Asked Questions

What product 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. Recalled by BASF Corporation. Units affected: 4560 kg.
Why was this product recalled?
Cross contamination: the excipient was found to be contaminated with theophylline.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 23, 2020. Severity: Moderate. Recall number: D-0149-2021.