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
Reported: December 23, 2020 Initiated: November 17, 2020 #D-0149-2021
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.
Details
- Recalling Firm
- BASF Corporation
- Units Affected
- 4560 kg
- Distribution
- USA Nationwide and Worldwide
- Location
- Florham Park, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by BASF Corporation. Units affected: 4560 kg.
Why was this product recalled? ▼
Cross contamination: the excipient was found to be contaminated with theophylline.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 23, 2020. Severity: Moderate. Recall number: D-0149-2021.
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