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

FDA recall notice · announced December 23, 2020 · Basf

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: USA Nationwide and Worldwide
Lot/code information: Batch # 18472036, 18472041.
Quantity: 4560 kg
Status: Completed
Products in this recall event:
- 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 Siegfrie (D-0149-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.