FDA recall D-0149-2021

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.

Distribution

USA Nationwide and Worldwide

Key facts

Status

Completed

Initiation date

2020-11-17

Report date

2020-12-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Florham Park, NJ, United States

Primary source

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