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U.S. Department of Health and Human Services

Enforcement Report - Week of August 15, 2012

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Product Detail

Product Description Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-count (60 x 3 mL Sterile Unit-Dose Vials) per carton, Rx only, Manufactured by: nephron pharmaceuticals corporation, Orlando, FL 32811, NDC 0487-9501-60.
Recall Number D-1446-2012
Classification Class II
Code Info Lot #: A0654A, Exp 07/12; A0A62A, Exp 10/12
Product Distributed Qty 56,028 cartons
Reason For Recall Lack of Assurance of Sterility

Event Detail

Event Id 62604
Product Type Drugs
Status Ongoing
Recalling Firm Nephron Pharmaceuticals Corp.
City Orlando
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-06-22
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