Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville IN 46060 NDC#: 45183-0234-68.
Reported: September 3, 2014 Initiated: April 21, 2014 #D-1565-2014
Product Description
Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville IN 46060 NDC#: 45183-0234-68.
Reason for Recall
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Details
- Recalling Firm
- Pharmakon Pharmaceuticals
- Units Affected
- 20 vials
- Distribution
- United States: TX, IL, MD, IN
- Location
- Noblesville, IN
Frequently Asked Questions
What product was recalled? ▼
Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville IN 46060 NDC#: 45183-0234-68.. Recalled by Pharmakon Pharmaceuticals. Units affected: 20 vials.
Why was this product recalled? ▼
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 3, 2014. Severity: Critical. Recall number: D-1565-2014.
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