FDAFDA · Food and drugs·Recall number D-0140-2017
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.
Published November 23, 2016 · Recall initiated: November 9, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sandoz Inc
- Distributor
- Nationwide throughout the USA
- Lot
- Lot #: 2081915, 2082015, 2082115, 2082815, 2083115, Exp 08/17; 2090115, Exp 09/17
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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