Enforcement Report - Week of January 30, 2013
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Event Detail
| Event ID | 63971 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | West-ward Pharmaceutical Corp. |
| City | Eatontown |
| State | NJ |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-12-05 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide and Puerto Rico |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| PredniSONE Tablets, USP, 20 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1477-01), b) 500-count tablets per bottle (NDC 0143-1477-05), and c) 1000-count tablets per bottle (NDC 0143-1477-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatowntown, NJ 07724. | Lot #: 68581A, 68581B, 68382A, 68382B, 68578A, 68578B, 68579A, 68580A, 68582A, 68582B, Exp 01/15 | Class II | Presence of Foreign Substance: A complaint was received for black specks identified as stainless steel inclusions and cellulose with trace amounts of aluminum and iron-rich inclusions. | 60,289 bottles | D-133-2013 |
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