Enforcement Report - Week of January 9, 2013
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Product Detail
| Product Description | Methylprednisolone Acetate (PF) 40 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA |
|---|---|
| Recall Number | D-109-2013 |
| Classification | Class I |
| Code Info | All lot codes |
| Product Distributed Qty | 9062 vials |
| Reason For Recall | Non-Sterility |
Event Detail
| Event Id | 63305 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | New England Compounding Center |
| City | Framingham |
| State | MA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-09-26 |
| Initial Firm Notification of Consignee or Public | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Distribution Pattern | Nationwide |
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