Recalls / Class III

Class IIID-0634-2017

Product

Adalat CC (nifedipine) Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749501

Affected lot / code info

Lot #: BXCUE1A, Exp. 01/2019

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-0634-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.