Drug 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
D-0149-2021
Product summary
- Firm
- BASF Corporation
- Event
- Event 86805
- Status
- Completed
- Classification
- Class II
- Quantity
- 4560 kg
- Official record key
drug-enforcement:D-0149-2021
Official wording
Reason: Cross contamination: the excipient was found to be contaminated with theophylline.
Code information: Batch # 18472036, 18472041.
Distribution pattern: USA Nationwide and Worldwide
Derived failure modes
-
Unknown
Cross contamination: the excipient was found to be contaminated with theophylline.