The Recall Desk

FDA (Drugs) recall action 75654

Sandoz Inc recalled 2 products on 2016-11-23

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
2016-11-23
Critical
0
Units
52,375

Why these products were recalled

Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the 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.

1–2 of 2

  • SevereFDA (Drugs)··2016-11-23

    Sandoz Recalls L-Cysteine Hydrochloride Injection Due to Sterility Concerns

    Sandoz Inc. is recalling L-Cysteine Hydrochloride Injection vials because an FDA inspection raised concerns that the product's sterility may be compromised.

    Product
    L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package Vials (NDC 66758-005-01), packaged in 5 x 50 mL Vials per carton(NDC 66758-005-02), Rx only, Manufactured for: Sandoz, Inc., Princeton, NJ.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2016-11-23

    Sandoz Recalls L-Cysteine Hydrochloride Injection Due to Sterility Concerns

    Sandoz Inc. is recalling L-Cysteine Hydrochloride Injection because an FDA inspection raised concerns that the product's sterility may be compromised.

    Product
    L-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL Single Dose Vial (NDC 66758-004-01), packaged in 10 x 10mL Vials per carton (NDC 66758-004-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.
    Category
    Distribution
    0 states