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U.S. Department of Health and Human Services

Enforcement Report - Week of August 15, 2012

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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

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 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. Lot #: A0654A, Exp 07/12; A0A62A, Exp 10/12 Class II Lack of Assurance of Sterility 56,028 cartons D-1446-2012