Enforcement Report - Week of November 21, 2012
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Event Detail
| Event ID | 63585 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Ameridose LLC |
| City | Westborough |
| State | MA |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-10-31 |
| Initial Firm Notification of Consignee or Public | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Distribution Pattern | Nationwide |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| All Sterile Products manufactured by Ameridose LLC, Westborough, MA. A complete list of all products subject to this recall can be accessed on-line at www.ameridose.com | All lot codes within expiry | Class II | Lack of assurance of sterility | D-054-2013 | |
| All Non-Sterile Products manufactured by Ameridose LLC, Westborough, MA. A complete list of all products subject to this recall can be accessed on-line at www.ameridose.com | All lot codes within expiry | Class II | GMP deficiencies | D-055-2013 |
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