Recalls / Class III
Class IIID-0631-2017
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.
- Affected lot / code info
- Lot #: BXH1P51, BXH66D1, BXH1P51A, BXH5ZS1, Exp. 03/2018; BXH1P52, Exp. 05/2018; BXHBKF1A, and BXHB8S1A, Exp. 10/2018.
Why it was recalled
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Recalling firm
- Firm
- Alvogen, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 10 Bloomfield Ave Bldg B Ste 2, N/A, Pine Brook, New Jersey 07058-9743
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-03-07
- FDA classified
- 2017-04-04
- Posted by FDA
- 2017-04-12
- Terminated
- 2017-12-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0631-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.