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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 HYDROCORTISONE and ACETIC ACID OTIC SOLUTION, USP, 10 mL bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811; NDC 0603-7039-39; UPC 3 0603-7039-39 7.
Recall Number D-1411-2012
Classification Class III
Code Info Lot #: L072B11A, Exp 8/12; L102C11A, L103C11A, Exp 10/12; L046D11A, L082F11A, L089F11A, Exp 11/12; L148J11A, L149J11A, L150J11A, Exp 03/13; and L151J11A, Exp 04/13
Product Distributed Qty 54,431 bottles
Reason For Recall Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.

Event Detail

Event Id 62496
Product Type Drugs
Status Ongoing
Recalling Firm Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
City Huntsville
State AL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-06
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Puerto Rico.