Ketorolac Tromethamine Injection Recall Issued Due to Contamination
Published: October 22nd, 2009
The FDA posted a recall notice Wednesday from American Regent, indicating that all lots of Ketorolac Tromethamine, USP 30 mg/mL injections are being recalled due to the risk that they may be contaminated. This poses a serious risk for potentially life-threatening injuries, including blood clots, pulmonary embolism or anaphylactic reactions in some patients.
The Ketorolac Tromethamine Injection recall was issued after the manufacturer discovered that some of the vials contained particulate matter due to crystallization. According to American Regent, no injuries or deaths have been reported in conjunction with the contaminated drugs.
Ketorolac Tromethamine is the generic version of Toradol and Acular. It is a prescription non-steroidal anti-inflammatory drug (NSAID) also used as a pain killer and fever reducer. The generic being recalled is manufactured by Luitpold Pharmaceuticals, Inc., and distributed by American Regent, Inc.
“American Regent is undertaking this recall in consideration of the potential for safety issues if the product is administered to patients, including obstruction of blood vessels which can induce pulmonary emboli or thrombosis, activate platelets and/or neutrophils to induce anaphylactic reactions,” according to the press release issued by the company. “Other adverse effects associated with the injection of particulate matter include foreign body granulomas, and local irritation at the injection site.”
The package insert for the drug already warns that the vials should be inspected visually for particulate matter and discoloration before administering the drug, when possible. However, given the safety risk, American Regent issued a recall and will credit accounts for all returned Ketorolac Tromethamine Injection products.
The recalled drugs include all lots of American Regent’s Ketorolac Tromethamine Injection, USP 30 mg/mL; NDC# 0517-0801-25 30 mg/mL 1mL Single Dose Vial, and NDC# 0517-0902-25 30mg/mL 2mL Single Dose Vial (60mg/2mL). The recall does not include the 15 mg/mL injections. The contaminated drugs were sold to hospitals, clinics and other healthcare facilities nationwide.
Anyone with the recalled drugs should contact American Regent’s customer service department at 1-800-645-1706 to return the drugs and have their account credited for a full refund. Any adverse reactions should be reported to FDA’s MedWatch program.
Related Posts
- Caffeine and Sodium Benzoate Recall Issued Due to Particulate Matter (5/6/2011)
- Ammonium Molybdate Recall: Particles in Another American Regent Drug (4/28/2011)
- American Regent Sodium Chloride Recall: Particulate Contamination (3/17/2011)
- Sodium Thiosulfate Injection Recall Issued Due to Translucent Particles (2/4/2011)
- American Regent Drug Recall Expanded to Include Sodium Bicarbonate (12/29/2010)
Comment by Michelle on 10 June 2010:
Hello I saw my Dr. in December due to what I thought was a pulled muscle in my lower back/upper butt area. On this visit he didn’t even check me but just assumed it was swollen and asked the nurses to give me something for the pain. The nurses were busy because I waited in the room for 25 minutes then the Dr. stopped back in and said he will just give me two shots for the pain and swelling. He told me to bend over he would give them in my butt. I thought he was kidding at first but pulled my pants down a bit and he gave me two shots. I was given 2 units of Methylprednisolone 80m and 4 units of Ketorolac Tromethamine. I never felt so much pain in my life and now it is June 2010 and I still have a little black and blue mark where he gave me the shots and also have had nothing but pain and swelling ten times worse since the shots. I have been to the ER several times and had xrays and MRI’s done and they have only found fluid in my joints if anything. Is this medicine what has caused me this much pain till this day? My hip and upper back throb daily and my hip swells where I can feel a lump. My Dr. won’t answer my calls or see me.
Comment by Alan on 18 August 2010:
I had a shot of Toradol / Ketorolac Tromethanmine injection in my behind as well. I was in severe pain and could hardly walk. I asked for pain medication, but the doctor refused. The doctor stated that he would give me a Toradol shot though. The doctor stated that it would reduce the swelling and give me relief. I bent over and he stuck me in the butt with the needle, I left his office almost needing a wheel chair. Not even a day later the pain became very extremely bad and my muscle start contracting in my legs and face. I also had an allergic reaction and broke out in hives. I went to the emergency room and was provided with pain medication. The pain continue to be so bad that I could hardly bare to be alive. I finally was able to get a doctor to prescribe Oxycotin until I received steroid injections. The doctors would not comment on whether this medication caused the hives and muscle contraction. I look into the side effects of the medication and sure enough it explains these side effects. I am thinking of suing the doctor and the manufacture of this drug. I still after 3 years have muscle contractions in my legs, back, face and arms. The hives disappeared after about two weeks or so. If you have never had this drug, my suggestion is don’t get it, you are better off eating a bottle of aspirin or Excedrin than taking this medication.
Comment by Joyce on 26 August 2010:
i have a history of asthma ,im allergic to aspirin,i was seen in my primary care physician’s office for pain in my knee on 12/1/09.and a shot of Toradol was given to me.i went into acute respiratory within an hour after the shot.and was brought to emergency room where i did not respond and was intubated, put on ventilator.i was in ICU for 3 days.