Kollidon CL-M Crospovidone Ph.Eur.Type B recall: Contamination
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
Why was Kollidon CL-M Crospovidone Ph.Eur.Type B recalled?
Cross contamination: the excipient was found to be contaminated with theophylline.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Batch # 18472036, 18472041.
- 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
- Recalling firm
- BASF Corporation
- Quantity
- 4560 kg
- Distribution
- USA Nationwide and Worldwide
- Recall date
- December 23, 2020
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (drug)