BASF Recalls Crospovidone Excipient Due to Theophylline Contamination
BASF Corporation is recalling 4,560 kg of Kollidon CL-M Crospovidone excipient because it was found to be cross-contaminated with theophylline.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant contamination risks in pharmaceutical ingredients.
Plain-English summary
BASF Corporation is recalling 4,560 kg of Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized, packaged in 30 kg plastic drums. The product is identified by Batch # 18472036 and 18472041. The excipient was manufactured by BASF SE in Ludwigshafen, Germany, and co-manufactured by Siegfried PharmaChemikalien Minden GmbH in Minden, Germany.
The recall was initiated due to cross-contamination, as the excipient was found to be contaminated with theophylline. The product was distributed nationwide in the USA and worldwide.
This recall affects pharmaceutical manufacturers and distributors who purchased the specific batches of Kollidon CL-M Crospovidone. Consumers should not use the recalled product and should contact their supplier or BASF Corporation for further instructions.
The recalled product
- 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
- Manufacturer
- BASF Corporation
- Category
- Drug — Pharmaceutical Excipient
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Batch # 18472036
- 18472041.
Distribution
Distributed nationwide across the United States.
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