Reported Sep 3, 2014 · Terminated
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…
Pharmakon Pharmaceuticals
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Pharmakon Pharmaceuticals · 14450 Getz Rd · Noblesville, IN · 46060-3303
Is this the product you have?
- 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.
- Lot codes and dates
- A) Lot #: E21294DK1C
- Exp Date05/22/2014 B) Lot #: E21294DK3C
- Exp Date06/08/2014
- Amount recalled
- 10/50 mL bags, 40/100 mL bags
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Stop using this product now
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Using this product could cause serious injury, illness or death — stop using it now.
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