FDAFDA · Food and drugs·Recall number D-1514-2016
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.
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 #: a) 091914, Exp 09/16; b) 080114, Exp 08/16; 090414, 092614, Exp 09/16
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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