Ketorolac Tromethamine Injection Recall Issued Due to Contamination

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.

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“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.

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15 Comments

  • SheriApril 5, 2022 at 8:39 pm

    On 02/22/20 I noticed I was experiencing some issues with my vision but I drove myself to the hospital. They determined that i had a optical stroke. I was admitted On 02/25/20 a nurse came in with a syringe of Toradol. She inserted into my IV and immediately I felt severe burning in my arm up to my brain. She pushed with saline but when I opened my eyes I was totally blind. They redid my MRI and s[Show More]On 02/22/20 I noticed I was experiencing some issues with my vision but I drove myself to the hospital. They determined that i had a optical stroke. I was admitted On 02/25/20 a nurse came in with a syringe of Toradol. She inserted into my IV and immediately I felt severe burning in my arm up to my brain. She pushed with saline but when I opened my eyes I was totally blind. They redid my MRI and said my stroke had not changed. I have regain a small part of my vision but not much. They state my brain tissue was like blistered and is now gone. I had previously had kidney surgery and it has affected my kidneys as well. It is also listed as a allergy to toradol. They gave me 2 more after I refused them as well. If there is anyway you could help me I would be very grateful. I've been told I have to go after the manufacturer. I hope to hear from you. If I don't answer please leave a message. I can't always get to my phone quick enough to answer it.

  • DinahDecember 15, 2021 at 12:16 am

    Years ago I was involved in a car accident and was experiencing Soo much pain, I we to the hospital & was given Ketorolac in the left glute muscle. The injection site felt very warm to the touch, itchy, throbbing and it felt like something was eating away the tissue. I noticed a quarter sized dent and it has gotten bigger. I also have back pain, pain in my hip that makes me feel like my hip is goi[Show More]Years ago I was involved in a car accident and was experiencing Soo much pain, I we to the hospital & was given Ketorolac in the left glute muscle. The injection site felt very warm to the touch, itchy, throbbing and it felt like something was eating away the tissue. I noticed a quarter sized dent and it has gotten bigger. I also have back pain, pain in my hip that makes me feel like my hip is going to "give out". I wish I'd stayed home instead of going to the hospital.

  • LaurieDecember 8, 2021 at 2:53 am

    I was given torodol via IV shot went into shock and 5 days later admitted at same hospital for acute renal failure,

  • JameySeptember 14, 2019 at 3:36 pm

    After an initial dose was administered at a hospital for pain, I was prescribed ketoralac (max 2x monthly, but more often only once a month) for about 7 years before a pharmacist questioned why I was *just then* being prescribed acid reflux medication. Apparently they’re usually prescribed together because of ketoralacs damaging effects on stomach lining. I had just been released from the hospital[Show More]After an initial dose was administered at a hospital for pain, I was prescribed ketoralac (max 2x monthly, but more often only once a month) for about 7 years before a pharmacist questioned why I was *just then* being prescribed acid reflux medication. Apparently they’re usually prescribed together because of ketoralacs damaging effects on stomach lining. I had just been released from the hospital for reflux, a problem I’d never had before in all my years when I went to fill that Rx. I continued to be prescribed the Ketoralac. Fast forward a few years and one night I was as having bad stomach pain and suddenly it felt like fireworks were going off inside my stomach and burning all the way down. I had never felt anything like it. I think I passed out in the hospital from the pain. I remember nothing of my stay. I have developed pages of food sensitivities and continue to have intermittent, debilitating pain no matter what I eat.

  • ANTHONYJuly 1, 2019 at 2:50 pm

    My was was given Toradol / Ketorolac on Mary 7th 2019 and had a massive allergic reaction as a result. We believe she had a brain embolism and is now have sever speech and cognitive issues.

  • EugeneAugust 20, 2018 at 9:45 pm

    My wife died about 10 hours after receiving an injection of Toradol / Ketorolac Tromethanmine from her Primary Care Doctor.Could an Attorney please contact me ASAP

  • BonnieDecember 13, 2017 at 9:38 pm

    I received injection in Sept 2016Had severe burning after injection Now I have sever pain in buttocks,side of thigh and upper front thigh dr wants to treat me for previous back pain Sometime I can hardly put pressure on that leg Don't know if I'll suffer the rest of my life

  • stoneOctober 30, 2016 at 2:12 am

    I had a ketordac shot in my right upper arm at the shoulder, since the shot I'm experiencing feelings in the same lower arm of tingling and painful under the arm Pitt sensations of blood being cut off through the arm, I told my primary card doctor who ordered the shot when I asked her to step up my pain meds . I told her that I didn't want the shot she insisted that she wouldn't up my pain meds fo[Show More]I had a ketordac shot in my right upper arm at the shoulder, since the shot I'm experiencing feelings in the same lower arm of tingling and painful under the arm Pitt sensations of blood being cut off through the arm, I told my primary card doctor who ordered the shot when I asked her to step up my pain meds . I told her that I didn't want the shot she insisted that she wouldn't up my pain meds for my back pain put would give me a shot to treat the pain . I was in so much pain I had to do something I could always stop taking pills but no one can uptake a shot . This doctor has really screwed up my arm Pitt and arm with this ketordac pain shot everyday and every night I'm in pain level 8 or higher shoulder very very stiff unable to rotate it as I did normally before the shot and now I'm going to therapy for it. I don't advise anyone to ever get a shot you can't undo

  • michaelJune 24, 2015 at 11:20 pm

    I too have had multiple injections of this due to chronic back issues. these days I also have hip and leg problems as well since the injections. I have recently received a letter from my Dr office notifying me that the Toradol that I had been injected with many times was contaminated. Obviously they failed to follow procedure if they failed to physically inspect the material prior to injecting. Al[Show More]I too have had multiple injections of this due to chronic back issues. these days I also have hip and leg problems as well since the injections. I have recently received a letter from my Dr office notifying me that the Toradol that I had been injected with many times was contaminated. Obviously they failed to follow procedure if they failed to physically inspect the material prior to injecting. Also it appears that they missed the recall notice since I had been injected well after the recall was announced. Nice to know my health care team is truly looking out for my well being

  • LilaJanuary 14, 2013 at 12:24 am

    i have gotten two shots of Toreldol and now taking the pills however, my stomach has hurt so bad and I have had serious heart burn. I could only takr the pills for 5 days..WHY? even my insurance will not pay for more than 20 pills for 30 days. What is up with this medicine? I thought it was truly helping me, but now I feel terrible stomach aches. Anyone else experience this?

  • amyJanuary 8, 2013 at 9:40 am

    I have received several injections of toradol in my right buttocks. the Dr wouldn't tell me the name of the shot on two different occasions and I was never warned of any side effects. I now suffer from severe sciatic nerve pain and can barely stand up or walk even.

  • AundraDecember 30, 2012 at 2:59 am

    chronic pain after being injected with 60mg of taradol

  • JoyceAugust 26, 2010 at 2:20 pm

    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.

  • AlanAugust 18, 2010 at 4:09 am

    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[Show More]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.

  • MichelleJune 10, 2010 at 4:24 am

    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 tol[Show More]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.

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