D-0149-2021 Class II
Recall Details
- Product Type
- Drugs
- Report Date
- December 23, 2020
- Initiation Date
- November 17, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4560 kg
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.
Distribution Pattern
USA Nationwide and Worldwide
Code Information
Batch # 18472036, 18472041.