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U.S. Department of Health and Human Services

Enforcement Report - Week of October 30, 2013

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Event Detail

Event ID 66462
Product Type Drugs
Status Ongoing
Recalling Firm Nephron Pharmaceuticals Corp.
City Orlando
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-10-02
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Nationwide and Puerto Rico

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL for Oral Inhalation Only, Rx Only, 25 x 3 mL Sterile Unit-Dose Vials per carton, Manufactured By: Nephron Pharmaceuticals Corporation, Orlando, FL 32811, NDC 0487-9501-25 Lots #: A3A33A, A3A33B, A3A34A, A3A35A. A3A36A, A3A37A, A3A38A, Exp 06/15; A3A40A, A3A41A, A3A42A, Exp 07/15 Class II Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic process simulation and discovered bacterial growth in a number of media fill vials, exceeding the allowable limit. 689,568 cartons D-66462-001