D-0149-2021 Class II
FDA drug recall D-0149-2021 was initiated by BASF Corporation on Nov 17, 2020 and is designated Class II. Reason for recall: Cross contamination: the excipient was found to be contaminated with theophylline. Affected quantity: 4560 kg.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 23, 2020
- Initiation Date
- Nov 17, 2020
- 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.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0149-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026