November 2020 FDA Recall Drug by Basf Corporation
D-0149-2021 - Cross contamination
This Class II drug recall was voluntarily initiated by Basf Corporation on November 17, 2020 for the product Drug. The FDA reported the reason for recall as cross contamination. The product was distributed Nationwide and the recall is currently completed.
Recall Number: D-0149-2021
Cross contamination: the excipient was found to be contaminated with theophylline.
11-17-2020
12-23-2020
4560 kg
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
BASF Corporation
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA Nationwide and Worldwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Batch# 18472036, 18472041.
