Drug product
Nifedipine Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-370-01.
D-0631-2017
Product summary
- Firm
- Alvogen, Inc
- Event
- Event 76664
- Status
- Terminated
- Classification
- Class III
- Quantity
- N/A
- Official record key
drug-enforcement:D-0631-2017
Official wording
Reason: Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Code information: Lot #: BXH1P51, BXH66D1, BXH1P51A, BXH5ZS1, Exp. 03/2018; BXH1P52, Exp. 05/2018; BXHBKF1A, and BXHB8S1A, 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