Parker Waichman LLP

Cyanocobalamin Injection Recalled for Cracked Vials

Cyanocobalamin injection is being recalled by American Regent for cracked vials, the U.S. Food & Drug Administration (FDA) just announced. Cyanocobalamin Injection, USP, is manufactured by Luitpold Pharmaceuticals, Inc. and distributed by American Regent, Inc. of Shirley, New York. American Regent is conducting this nationwide recall at the retail and hospital level for Cyanocobalamin Injection, […]

Cyanocobalamin injection is being recalled by American Regent for cracked vials, the U.S. Food & Drug Administration (FDA) just announced. Cyanocobalamin Injection, USP, is manufactured by Luitpold Pharmaceuticals, Inc. and distributed by American Regent, Inc. of Shirley, New York.

American Regent is conducting this nationwide recall at the retail and hospital level for Cyanocobalamin Injection, USP, 1000 mcg/mL, 1 mL Vial NDC # 0517-0031-25. The recall involves Lot Number 1662 and Expiration Date: November 2013; Lot Number 1679 and Expiration Date: November 2013; and Lot Number 1683 and Expiration Date: November 2013. The recall was initiated on April 2, 2012 and involves no other lots or sizes of Cyanocobalamin Injection, USP.

American Regent learned that cracks can form in the heel (bottom) and sides of some vials of the recalled lots. This may lead to contamination and the potential for glass particulates. Cracks were observed in lot 1683; however, lots 1662 and 1679 are also being recalled because they were manufactured with the same lot of glass vials as lot 1683. To date, American Regent has not received any reports of adverse events related to these defective lots.

The intramuscular or subcutaneous injection of a solution whose sterility may have been compromised may result in a systemic infection, abscess formation, or infection at the injection site, said the FDA. Muscle and adipose tissue damage may occur when solutions containing particulates are injected intramuscularly or subcutaneously.

Cyanocobalamin Injection, USP is indicated for vitamin B12 deficiencies due to malabsorption, which may be associated with Addisonian (pernicious) anemia; gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, or total or partial gastrectomy; fish tapeworm infestation; malignancy of the pancreas or bowel; or folic acid deficiency.

The recalled Cyanocobalamin Injection, USP was distributed to wholesalers and distributors nationwide. Hospitals, retail pharmacies, clinics and physician offices, and other healthcare facilities and providers are advised to not use the recalled American Regent Cyanocobalamin Injection, USP. These products should be immediately quarantined for return.

American Regent is advising its distributors and consumers by email, fax, and/or overnight courier of the recall and is arranging for return of all the recalled Cyanocobalamin Injection, USP. Consumers, distributors, and retailers in possession of the recalled Cyanocobalamin Injection, USP are advised to stop its use.

American Regent said it will credit accounts for all returned recalled Cyanocobalamin Injection. American Regent Customer Service can be reached, toll-free, at 1.800.645.1706, Monday through Friday, from 8:30 a.m. to 7:00 p.m., Eastern Time (ET). Hospitals, emergency rooms, clinics, and other healthcare facilities and providers, or patients with product quality complaints, medical, or other questions can reach Professional Services, toll-free, at 1.877.788.3232, Monday through Friday, from 9:00 a.m. to 5:00 p.m., ET. Adverse reactions should be reported to American Regent via email at pv@luitpold.com; by fax to 1.610.650.0180, or by telephone, toll-free, at 1.800.734.9236, Monday through Friday, 9:00 am. to 5:00 p.m., ET.

Adverse reactions or quality problems should also be reported to FDA’s MedWatch Adverse Event Reporting program online, by regular mail, or by fax: Online: www.fda.gov/medwatch/report.htm; Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to the address on the pre-addressed form; or Fax: 1-800-FDA-0178.

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
Ashley L worked with me kept me updated and informed on everything that was going on with my case in a timely and professional manner.
Larry Lutes
3 years ago
5 Star Reviews 150
I used Parker waichman for my wtc victim compensation suit. They were amazing. They did everything for me and the staff was extremely friendly and knowledgeable of all my needs. I highly recommend parker waichman to anyone who needs legal advice or service.
paulsr
a month ago
5 Star Reviews 150
i was lucky to have had Benita Rollis help me with my claim. She answered all my questions and helped me throughout this long process. She was always helpful and got back to me in a timely manner.
Tommy
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