Drug product
Nifedipine Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-369-01.
D-0630-2017
Product summary
- Firm
- Alvogen, Inc
- Event
- Event 76664
- Status
- Terminated
- Classification
- Class III
- Quantity
- N/A
- Official record key
drug-enforcement:D-0630-2017
Official wording
Reason: Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Code information: Lot #: BXH1P41, BXH1BEE1, BXH1BE2, BXH1BE1B, BXH1BE1A, BXH1P41A, Exp. 01/2018; BXH81R1, BXHBD41A, BXH5ZR1, BXH9AL1A, Exp. 06/2018; BXHCUD1A, BXHCUF2A, Exp. 01/2019.
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib