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MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Ibuprofen Lysine Injection, 20 mg /2 mL (10 mg/mL) by Exela Pharma Sciences: Recall - Particulate Matter
AUDIENCE: Pediatrics, Cardiology, Critical Care Medicine
ISSUE: Exela Pharma Sciences, in association with marketer X-Gen Pharmaceuticals, Inc., is voluntarily recalling lot number PLND1613 of Ibuprofen Lysine Injection, 20 mg /2 mL (10 mg/mL), vials to the hospital or user level. Some of the vials have been found to contain particulate matter.
Particulate matter has the potential to block blood vessels, provoke an immune reaction, and/or lead to microinfarcts which could be life threatening. Neither Exela nor X-Gen has received any reports of adverse events related to this recall.
BACKGROUND: Ibuprofen Lysine Injection is indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management is ineffective. The product is packaged in three 2 mL Single-Dose vials per carton.
- NDC 39822-1030-2
- Lot PLND1613
- Expiration Date 02/2018
The product was distributed nationwide to wholesalers and distributors for further distribution to hospitals and retail customers.
RECOMMENDATION: X-Gen is notifying its distributors and customers by emails and fax communications and is arranging for return of all recalled products. Consumers/distributors/
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the press release, at:
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