Parker Waichman LLP

NeoProfen Injection Recalled, FDA Warns Of Temporary Shortage

Lundbeck Inc. has voluntarily recalled two lots of NeoProfen® (ibuprofen lysine) Injection that failed to meet a visible particulate quality requirement, the U.S. Food and Drug Administration (FDA) just announced. These two lots are the only lots currently available to prescribers and, therefore, the recall will result in a temporary drug shortage. This voluntary recall […]

Lundbeck Inc. has voluntarily recalled two lot<"https://www.yourlawyer.com/practice_areas/defective_drugs">s of NeoProfen® (ibuprofen lysine) Injection that failed to meet a visible particulate quality requirement, the U.S. Food and Drug Administration (FDA) just announced.

These two lots are the only lots currently available to prescribers and, therefore, the recall will result in a temporary drug shortage. This voluntary recall is the result of the company’s inspections of the two product lots of NeoProfen.

The NeoProfen recall, NDC 67386–122-52, includes product lots 1734991 (expiration date: April, 2011) and 1922319 (expiration date: March, 2012).

NeoProfen is a non-steroidal anti-inflammatory therapy indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants who weigh between 500 and 1500 g and who are no more than 32 weeks gestational age when usual medical management, such as fluid restriction, diuretics, respiratory support, etc., is ineffective.

To date, the company has not received adverse event reports or product complaints attributable to visible particulates from any lot of NeoProfen, including the lots that are being recalled. Particulate matter has the potential to obstruct blood vessels, which could induce pulmonary emboli or activate platelets and/or neutrophils to induce anaphylactic reactions.

Other adverse effects associated with intravenous injection of particulate matter include foreign body granulomas and local irritation of blood vessels. The potential adverse events resulting from the use of a sterile injectable product with particulates can be very serious and potentially fatal. Because of this, the company is conducting a voluntary recall as a safety precaution and will continue to closely monitor for reports of adverse drug reactions and product complaints.

This recall is being conducted with the knowledge of the FDA and notification of the recall and resulting product shortage has been sent to all wholesalers who have received these lots, all hospital pharmacies, and prescribing neonatologists.

For medical information questions about NeoProfen, please call 866-402-8520, toll-free, or email luinc-druginfo@lundbeck.com. Product complaints related to NeoProfen should be reported to 800-455-1141 (toll-free telephone), Monday to Friday from 8:00 a.m. to 5:00 p.m. central time, 847-282-1003 (fax), or luinc_safety@lundbeck.com.

Any adverse events that may be related to the use of these products should be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178; or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787l or on the MedWatch website at http://www.fda.gov/safety/medwatch/default.htm. 


What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Positive: Quality
Juan Jerez
3 years ago
5 Star Reviews 150
i want to thank Parker Waichman for taking care of my case. I especially want to thank Kathy Senedacor for her time care and professionalism. Parker Waichman is very fortunate to have her representing them.
nicholas cardascia
5 years ago
5 Star Reviews 150
Positive: Professionalism
James Carr
3 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038