Reported Dec 23, 2020 · Completed

Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized, packaged in 30 kg plastic drums, Manufacturer: BASF…

BASF Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: BASF Corporation · 100 Park Ave · Florham Park, NJ · 07932-1049

Is this the product you have?

  • Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized, packaged in 30 kg plastic drums
  • ManufacturerBASF SE, Carl-Bosch-Strabe 38, 67056 Ludwigshafen, Germany, Co-Manufactured by Siegfried PharmaChemikalien Minden GmbH, D-32423 Minden
Lot codes and dates
    • Batch # 18472036
    • 18472041
Amount recalled
4560 kg

Where it was sold

  • Nationwide

Why it was recalled

Cross contamination: the excipient was found to be contaminated with theophylline.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 7:23 PM UTC

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