Recall record at a glance
| Official record | D-1438-2012 |
|---|---|
| Category | Drug Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | West-ward Pharmaceutical Corp. |
| Report date | Aug 8, 2012 |
| Recall initiation date | Apr 13, 2012 |
| Quantity | a) 74,960 vials; b) 911,070 vials |
| Location | Eatontown, NJ, United States |
Official product description
Fosphenytoin Sodium Injection, USP, 500 mg PE per 10 mL (50 mg PE per mL), 10 mL Single Dose Vial, packaged in 10-count x 10 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 0143-9703-10), b) West-Ward (NDC 0143-9782-10).
Why the product was recalled
Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.
Distribution information
All lots were distributed throughout the US.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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