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. |
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