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U.S. Department of Health and Human Services

Enforcement Report - Week of July 18, 2012

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Product Detail

Product Description Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL, a) 15 mL Unit Dose Cups (50 unit dose cups per case), b) 473 mL Bottles, C III, Rx Only, Warning May be habit forming, Manufactured by VistaPharm, Largo, FL 33771, NDC a) 66689-023-50, b) NDC 66689-023-16.
Recall Number D-1416-2012
Classification Class II
Code Info Lot #'s a) 251400, Exp 07/13; b) 251500 Exp 07/13.
Product Distributed Qty a) 949 Cases, b) 188 bottles
Reason For Recall Impurities/Degradation Products: exceeded specification at 3 month stability testing

Event Detail

Event Id 62405
Product Type Drugs
Status Ongoing
Recalling Firm VistaPharm, Inc.
City Largo
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-30
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide