FDAFDA · Food and drugs·Recall number D-1566-2014
Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx Only. Labeled A) 50 mL, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060. NDC#: 45183-0989-41. B) 100 mL, Pharmakon Pharmaceuticals, 14450 Getz Rd., Noblesville, IN 888-660-6715. NDC#: 45183-0796-48.
Published September 3, 2014 · Recall initiated: April 21, 2014
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
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Pharmakon Pharmaceuticals
- Distributor
- United States: TX, IL, MD, IN
- Lot
- A) Lot #: E21294DK1C; Exp Date: 05/22/2014 B) Lot #: E21294DK3C; Exp Date: 06/08/2014
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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