The Recall Desk

FDA (Drugs) recall action 77545

Alvogen, Inc recalled 3 products on 2017-07-12

The FDA (Drugs) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2017-07-12
Critical
0
Units
—

Why these products were recalled

Lack of Assurance of Sterility

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

1–3 of 3

  • SevereFDA (Drugs)··2017-07-12

    Alvogen Recalls Clindamycin Injection Vials Due to Sterility Concerns

    Alvogen, Inc. is recalling 72,575 vials of Clindamycin Injection USP due to a lack of assurance of sterility. The affected lots were distributed nationwide.

    Product
    Clindamycin Injection USP; 600 mg/4 mL (150 mg/mL). 4 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-463-69
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2017-07-12

    Alvogen Recalls Clindamycin Injection Vials Due to Sterility Concerns

    Alvogen, Inc. is recalling specific lots of Clindamycin Injection USP due to a lack of assurance of sterility. The recall covers 71,825 vials distributed nationwide.

    Product
    Clindamycin Injection USP; 900 mg/6 mL (150 mg/mL). 6 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-464-69
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2017-07-12

    Alvogen Recalls Clindamycin Injection Vials Due to Sterility Concerns

    Alvogen, Inc. is recalling 5,100 vials of Clindamycin Injection USP due to a lack of assurance of sterility. The affected product was distributed nationwide.

    Product
    Clindamycin Injection USP; 300 mg/2 mL (150 mg/mL). 2 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-462-69
    Category
    Distribution
    0 states