Recalls / Class III

Class IIID-0628-2017

Product

Adalat CC (nifedipine) Extended Release Tablets 30 mg, 100-count bottles, Rx only, Manufactured for Bayer Healthcare Bayer Healthcare Pharmaceuticals Inc. Whippany, NJ 07901 Manufactured in Germany, NDC 50419-701-05

Affected lot / code info

Lot #: BXH1P21A, Exp. 11/2017

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-0628-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.