Drug product
Nifedipine Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-368-01.
D-0627-2017
Product summary
- Firm
- Alvogen, Inc
- Event
- Event 76664
- Status
- Terminated
- Classification
- Class III
- Quantity
- N/A
- Official record key
drug-enforcement:D-0627-2017
Official wording
Reason: Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Code information: Lot #: BXH1P22, BXH1P21A, BXH1P21, BXH1P31, BXH1P21B, Exp. 11/2017; BXH6EL1, BXH66A1, BXH6EN1, BXH6EP1, BXH6ER1, Exp. 06/2018; BXH81K1A, BXHBJD1A, Exp. 10/2018
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib