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Medication Safety Alerts

Ibuprofen Lysine Injection 20 mg/2 mL single dose vials Voluntary Recall

4/12/2017

On April 12, 2017, the United States Food and Drug Administration (FDA) issued a voluntary recall of ibuprofen lysine injection 20 mg/2 mL single dose vials NDC #’s 39822-1030-01 (single vial) and 39822-1030-02 (carton) distributed by X-Gen Pharmaceuticals. This recall was issued because it may contain particle matter.

This may represent a potential health hazard or safety risk to plan members who may be using product affected by this recall.

This recall affects lot number PLND1613 exp 02/18. To see if you have affected product, please check the lot number. The lot number can be found on the bottom of the manufacturer’s carton and on the right hand side of the manufacturer’s label on the vial. If your product is not from lot number PLND1613, it is not affected by this recall. If your product is from lot number PLND1613, please contact the pharmacy that filled your prescription for further instructions.

You should not continue to use product that is affected by this recall. Please call your doctor right away for advice if you may be using affected product. Your doctor is familiar with your medical history and can suggest the best treatment option for you. If you need a prescription for a different medicine, please call your doctor.

CVS Caremark Response:

Please note: This product is not carried by the CVS Caremark Mail Service Pharmacies.

If you are currently using ibuprofen lysine injection 20 mg/2 mL single dose vials and have questions regarding this recall, please call your doctor or call X-Gen Pharmaceuticals toll-free at1-866-390-4411, Monday through Friday, 8:00 am through 5:00 pm (ET). You may also call the FDA consumer inquiry line toll-free at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit https://www.accessdata.fda.gov.

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