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U.S. Department of Health and Human Services

Enforcement Report - Week of June 18, 2014

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Product Detail

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.
Recall Number D-1362-2014
Classification Class I
Code Info Lot #: E1016227C, Exp. 4/21/2014; E0433735C, Exp. 4/20/2014
Product Distributed Qty 80 syringes
Reason For Recall Superpotent Drug: Product contains twice the stated amount of midazolam.

Event Detail

Event Id 67903
Product Type Drugs
Status Ongoing
Recalling Firm Pharmakon Pharmaceuticals
City Noblesville
State IN
Country US
Voluntary / Mandated
Recall Initiation Date 2014-03-26
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern IN