D-0628-2017 Class III Terminated
FDA drug recall D-0628-2017 was initiated by Alvogen, Inc on March 7, 2017 and is designated Class III. Reason for recall: Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib The recall status is terminated (terminated December 15, 2017). Affected quantity: N/A.
Recall Details
- Product Type
- Drugs
- Report Date
- April 12, 2017
- Initiation Date
- March 7, 2017
- Termination Date
- December 15, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Adalat CC (nifedipine) Extended Release Tablets 30 mg, 100-count bottles, Rx only, Manufactured for Bayer Healthcare Bayer Healthcare Pharmaceuticals Inc. Whippany, NJ 07901 Manufactured in Germany, NDC 50419-701-05
Reason for Recall
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Distribution Pattern
Nationwide
Code Information
Lot #: BXH1P21A, Exp. 11/2017