FDA Drug recall D-0149-2021
Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized, packaged in 30 kg plastic drums, Manufacturer: BASF SE, Carl-Bosch-Strabe…
- FDA Drug
- Class II
- completed
- Published 2020-12-23
On 2020-12-23 the FDA classified a Class II recall of Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized, packaged in 30 kg plastic drums, Manufacturer: BASF SE, Carl-Bosch-Strabe… by Basf, citing cross contamination: the excipient was found to be contaminated with theophylline.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0149-2021 |
| Classification | Class II |
| Status | completed |
| Initiated | 2020-11-17 |
| Published | 2020-12-23 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Basf |
| Distribution | US |
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
Cross contamination: the excipient was found to be contaminated with theophylline.
Identifiers
| code_info | Batch # 18472036, 18472041. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0149-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.