The Recall Desk

FDA (Drugs) recall action 75032

Sandoz Inc recalled 2 products on 2016-09-28

The FDA (Drugs) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2016-09-28
Critical
0
Units
32,099

Why these products were recalled

Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • SevereFDA (Drugs)··2016-09-28

    Sandoz Recalls Phenylephrine Injection Due to Sterility Concerns

    Sandoz Inc. is recalling specific lots of Phenylephrine HCI Injection because an FDA inspection raised concerns that the product's sterility may be compromised.

    Product
    Phenylephrine HCI Injection, USP, 10mg/mL, packaged in a) 5 mL Vial, 50 mg/5 mL (NDC 66758-016-03), 25 x 5 mL Vials per carton (NDC 66758-016-04) and b) 10 mL Vials, 100 mg/10 mL (NDC 66758-017-01), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2016-09-28

    Sandoz Recalls Ephedrine Sulfate Injection Due to Sterility Concerns

    Sandoz Inc. is recalling specific lots of Ephedrine Sulfate Injection because an FDA inspection raised concerns that the product's sterility may be compromised.

    Product
    Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 66758-008-01), packaged in 25 x 2 mL Vials per carton (NDC 66758-008-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.
    Category
    Distribution
    1 state