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

FDA Recall #D-0149-2021 — Class II — November 17, 2020

Recall #D-0149-2021 Date: November 17, 2020 Classification: Class II Status: Completed

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.

Recalling Firm

BASF Corporation — Florham Park, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

4560 kg

Distribution

USA Nationwide and Worldwide

Code Information

Batch # 18472036, 18472041.

Status

Completed

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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