Enforcement Report - Week of August 8, 2012
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Product Detail
| Product Description | Fosphenytoin Sodium Injection, USP, 100 mg PE per 2 mL (50 mg PE per mL), 2 mL Single Dose Vial, packaged in 25-count x 2 mL Single Dose Vials per carton, Rx only, Mfd. By: Hikma Farmaceutica (Portugal), S.A.; Dist. By: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724 USA under the labels a) NOVAPLUS (NDC 0143-9704-25), b) West-Ward (NDC 0143-9788-25). |
|---|---|
| Recall Number | D-1437-2012 |
| Classification | Class II |
| Code Info | Lot #s: a) 113153.1, 113154.1, 113155.1, Exp 05/13; 113248.1, Exp 07/13; b) 103196.1, 103197.1, 103197.2, 103198.1, Exp 07/12; 103317.1, 103318.1, 103319.1, 103345.1, 103345.2, Exp 11/12; 103346.1, 103347.1, 103348.1, 103349.1, 103350.1, Exp 12/12; 113030.1, 113031.1, 113032.1, 113033.1, 113034.1, 113035.1, 113036.1, Exp 01/13; 113245.1, 113246.1, 113247.1, Exp 07/13 |
| Product Distributed Qty | a) 308,275 vials; b) 2,008,850 vials |
| Reason For Recall | Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples. |
Event Detail
| Event Id | 62627 |
|---|---|
| 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 | 2012-04-13 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | All lots were distributed throughout the US. |
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