FDAFDA · Food and drugs·Recall number D-1513-2016
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.
Published September 28, 2016 · Recall initiated: August 24, 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 product sterility may be compromised.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sandoz Inc
- Distributor
- Nationwide and Puerto Rico
- Lot
- Lot #: 080514, 080614, 081114, 081214, 081314, 081414, 082714, 082814, 082914, Exp 08/16; 090214, 090314, 090814, 090914, 091014, 091114, 091214, 091514, Exp 09/16
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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