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U.S. Department of Health and Human Services

Enforcement Report - Week of July 18, 2012

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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
Distribution Pattern Nationwide and Puerto Rico.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. 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 Class III Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point. 54,431 bottles D-1411-2012