FDAClass ISeptember 3, 2014

Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in recall

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.…

Why was Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in recalled?

Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

A) Lot #: E21294DK1C; Exp Date: 05/22/2014 B) Lot #: E21294DK3C; Exp Date: 06/08/2014

Product
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.…
Recalling firm
Pharmakon Pharmaceuticals
Quantity
10/50 mL bags, 40/100 mL bags
Distribution
United States: TX, IL, MD, IN
Recall date
September 3, 2014
Classification
Class I
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls