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Class I · Most seriousRecall completed

Ibuprofen Lysine

A reasonable chance it could cause serious harm or death.

Does this affect you?
Check your lot numberPLND1613, Exp 02/18
Where it was soldNationwide in the USA.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Presence of Particulate Matter

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byExela Pharma Sciences, LLC, Lenoir, NC 28645
Brand nameIBUPROFEN LYSINE
Generic nameIBUPROFEN LYSINE
Active ingredient(s)IBUPROFEN LYSINE
Distributed by / forX-Gen Pharmaceuticals, Inc., Big Flats, NY 14814;
NDC39822-1030-1
Show the full FDA record
Full product labelIbuprofen Lysine Injection, 20 mg/2 mL (10 mg/mL), 2 mL Single-Dose Vial (NDC 39822-1030-1), packaged in 3 x 2 mL Single-Dose Vials per carton (NDC 39822-1030-2); Rx only, Distributed by: X-Gen Pharmaceuticals, Inc., Big Flats, NY 14814; Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645.
Recalling firmX-Gen Pharmaceuticals Inc.
DistributionNationwide in the USA.
Quantity2593 cartons
Recall initiated2017-02-08
Report date2017-04-12
Recall completed2020-06-10
Recall numberD-0637-2017
ClassificationClass I
FDA statusTerminated
Origin on fileHorseheads NY United States

Related

Ibuprofen recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.