Drug product
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
D-0628-2017
Product summary
- Firm
- Alvogen, Inc
- Event
- Event 76664
- Status
- Terminated
- Classification
- Class III
- Quantity
- N/A
- Official record key
drug-enforcement:D-0628-2017
Official wording
Reason: Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Code information: Lot #: BXH1P21A, Exp. 11/2017
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib