Class II
Completed
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
This recall has been completed (originally issued December 23, 2020).
- Company
- Basf Corporation
- Recall Initiated
- November 17, 2020
- Posted
- December 23, 2020
- Recall Number
- D-0149-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 4560 kg
- Firm Location
- Florham Park, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Cross contamination: the excipient was found to be contaminated with theophylline.
Distribution
USA Nationwide and Worldwide
Lot / Code Info
Batch # 18472036, 18472041.
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