Enforcement Report - Week of November 28, 2012
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Product Detail
| Product Description | Orajel Kids My Way! Anticavity Fluoride (sodium fluoride) toothpaste, 0.24%, 3 oz (85 g) pump, Church & Dwight Col, Inc., Princeton, NJ 08543; UPC 3 10310 32370 7. |
|---|---|
| Recall Number | D-061-2013 |
| Classification | Class II |
| Code Info | Lot #: BI1041, Exp 02/13 |
| Product Distributed Qty | 42,768 pumps |
| Reason For Recall | CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substituted for PEG. |
Event Detail
| Event Id | 62461 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Church & Dwight Inc |
| City | Princeton |
| State | NJ | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-09-06 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide |
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