FDAFDA · Food and drugs·Recall number D-0141-2017
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.
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 #: 2070915, 2071015, 2071415, 2071515, 2071615, 2071715, 2072115, 2072215, Exp 07/17; 2092315, 2093015, Exp 09/17; 2100115, Exp 10/17; 2120115, 2120215, Exp 12/17
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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