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D-1362-2014 Class I Terminated

Recalled by Pharmakon Pharmaceuticals — Noblesville, IN

FDA drug recall D-1362-2014 was initiated by Pharmakon Pharmaceuticals on Mar 26, 2014 and is designated Class I. Reason for recall: Superpotent Drug: Product contains twice the stated amount of midazolam. The recall status is terminated (terminated Jul 31, 2014). Affected quantity: 80 syringes.

Recall Details

Product Type: Drugs
Report Date: Jun 18, 2014
Initiation Date: Mar 26, 2014
Termination Date: Jul 31, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 80 syringes

Product Description

Midazolam 0.2 mg/2 mL 0.9% Sodium Chloride syringes, Total dosage: 0.4 mg per 2 mL, Rx Only, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd, Noblesville, Indiana, NDC 45183-0014-69.

Reason for Recall

Superpotent Drug: Product contains twice the stated amount of midazolam.

Distribution Pattern

Code Information

Lot #: E1016227C, Exp. 4/21/2014; E0433735C, Exp. 4/20/2014

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1362-2014
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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