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.
Reported: September 3, 2014 Initiated: April 21, 2014 #D-1566-2014
Product Description
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.
Reason for Recall
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Details
- Recalling Firm
- Pharmakon Pharmaceuticals
- Units Affected
- 10/50 mL bags, 40/100 mL bags
- Distribution
- United States: TX, IL, MD, IN
- Location
- Noblesville, IN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Pharmakon Pharmaceuticals. Units affected: 10/50 mL bags, 40/100 mL bags.
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-1566-2014.
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