Recalls / Class III
Class IIID-0627-2017
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.
- Affected lot / code info
- Lot #: BXH1P22, BXH1P21A, BXH1P21, BXH1P31, BXH1P21B, Exp. 11/2017; BXH6EL1, BXH66A1, BXH6EN1, BXH6EP1, BXH6ER1, Exp. 06/2018; BXH81K1A, BXHBJD1A, 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-0627-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.