Home / Recalls / Pharmakon Pharmaceuticals / D-1566-2014

D-1566-2014 Class I Terminated

Recalled by Pharmakon Pharmaceuticals — Noblesville, IN

FDA drug recall D-1566-2014 was initiated by Pharmakon Pharmaceuticals on Apr 21, 2014 and is designated Class I. Reason for recall: Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. The recall status is terminated (terminated Dec 3, 2014). Affected quantity: 10/50 mL bags, 40/100 mL bags.

Recall Details

Product Type: Drugs
Report Date: Sep 3, 2014
Initiation Date: Apr 21, 2014
Termination Date: Dec 3, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 10/50 mL bags, 40/100 mL bags

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.

Distribution Pattern

United States: TX, IL, MD, IN

Code Information

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

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1566-2014
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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