The Recall Desk

FDA (Drugs) recall action 76664

Alvogen, Inc recalled 9 products on 2017-04-12

The FDA (Drugs) publishes a recall like this one as 9 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 9 pages.

Products
9
Announced
2017-04-12
Critical
0
Units

Why these products were recalled

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

The agency’s own wording, quoted from the enforcement report.

1–9 of 9

  • LowFDA (Drugs)··2017-04-12

    Alvogen Recalls Adalat CC Tablets Due to Sorafenib Cross-Contamination

    Alvogen is recalling specific lots of Adalat CC (nifedipine) extended-release tablets due to cross-contamination with sorafenib powder.

    Product
    Adalat CC (nifedipine) Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749401
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2017-04-12

    Alvogen Recalls Nifedipine Tablets Due to Sorafenib Cross-Contamination

    Alvogen Inc. is recalling Nifedipine Extended-Release Tablets, 90 mg, due to cross-contamination with sorafenib powder found in the inlet air duct.

    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.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2017-04-12

    Alvogen Recalls Adalat CC Tablets Due to Sorafenib Cross-Contamination

    Alvogen, Inc. is recalling Adalat CC (nifedipine) 90 mg extended-release tablets because residual sorafenib powder was found in the manufacturing equipment's inlet air duct.

    Product
    Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749601
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2017-04-12

    Adalat CC Tablets Recalled for Sorafenib Cross-Contamination

    Alvogen, Inc. is recalling Adalat CC (nifedipine) Extended Release Tablets 30 mg due to cross-contamination with sorafenib powder.

    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
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2017-04-12

    Alvogen Recalls Nifedipine Extended-Release Tablets Due to Sorafenib Cross-Contamination

    Alvogen, Inc. is recalling Nifedipine Extended-Release Tablets, 30 mg, due to cross-contamination with sorafenib powder found in the manufacturing facility's inlet air duct.

    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.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2017-04-12

    Alvogen Recalls Adalat CC Tablets Due to Sorafenib Cross-Contamination

    Alvogen, Inc. is recalling Adalat CC (nifedipine) 60 mg extended-release tablets because residual sorafenib powder was found in the manufacturing facility's inlet air duct.

    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
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2017-04-12

    Adalat CC Tablets Recalled for Sorafenib Cross-Contamination

    Alvogen, Inc. is recalling Adalat CC (nifedipine) Extended Release Tablets due to cross-contamination with sorafenib powder found in the manufacturing facility.

    Product
    Adalat CC (nifedipine) Extended Release Tablets, 60 mg, 100- count bottles, Rx only Manufactured for Almatica, Almatica Pharma Inc. Pinebrook, NJ 07058 USA, NDC 50419-702-05
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2017-04-12

    Alvogen Recalls Nifedipine Extended-Release Tablets Due to Cross-Contamination

    Alvogen, Inc. is recalling Nifedipine Extended-Release Tablets, 60 mg, due to cross-contamination with sorafenib powder found in the manufacturing facility's inlet air duct.

    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.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2017-04-12

    Alvogen Recalls Adalat CC Tablets Due to Sorafenib Cross-Contamination

    Alvogen, Inc. is recalling specific lots of Adalat CC (nifedipine) Extended-Release Tablets due to cross-contamination with sorafenib powder.

    Product
    Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 50419-70305
    Category
    Distribution
    0 states