Enforcement Report - Week of August 1, 2012
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Product Detail
| Product Description | Erythromycin Topical Solution USP, 2%, 60 mL bottle with applicator, Rx only. E. FOUGERA & CO., A division of Fougera Pharmaceuticals, Inc., Melville, New York 11747, NDC 0168-0215-60, UPC 3 0168-0215-60 0. |
|---|---|
| Recall Number | D-1426-2012 |
| Classification | Class III |
| Code Info | Lot #: 418N, Exp 06/13 |
| Product Distributed Qty | 444 bottles |
| Reason For Recall | Chemical Contamination: This product is being recalled because trace amounts of a plasticizer (Di-Octyl Phthalate) may be present in the product. |
Event Detail
| Event Id | 62136 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Fougera Pharmaceuticals, Inc. |
| City | Hicksville |
| State | NY | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-06-07 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide. |
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