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Generic Toradol Recalled for Contamination

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Ketorolac Tromethamine may contain particles that can cause blod clots, allergic reactions, or death.

Wednesday, April 22, 2020 - COVID social distancing rulesFresenius Kabi USA, LLC has announced that it is recalling 13 lots of Ketorolac Tromethamine Injection, a generic form of the painkiller commonly sold under the brand name Toradol, after particulate matter that could cause vessel obstruction, blood clots, scarring, and allergic reactions was found in several vials.

Though Toradol, which is manufactured and sold by Pfizer, is not involved in this recall, medical facilities may use Fresnius Kabi's Ketorolac Tromethamine injections as an alternative. Ketorolac Tromethamine is an anti-inflammatory drug used to monitor severe acute pain for up to five days. It is most commonly used after surgeries.

According to the FDA, 13 lots of Ketorolac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill, and Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL fill, both distributed in 2 mL amber vials have been recalled. Particulate matter comprised of carbon, silicone, oxygen, and polyamides was found in eight sample vials.

Recalled lots were sold to pharmacies, hospitals, wholesalers, and distributors between May 5, 2018 and December 16, 2019.

Fresenius Kabi reports that it is in the process of notifing customers and distributors of the recall. Unused Ketorolac Tromethamine should be returned to Fresenius Kabi USA, LLC.The following lots should be removed from shelves and discontinued:

Ketorolac Tromethamine Injection, USP

30 mg / mL, 1 mL fill in a 2 mL amber vial

NDC #63323-162-01

Product Code 160201

Batch Numbers: 6118737,6118902, 6119052, 6119752, 6122349, 6122538

Ketorolac Tromethamine Injection, USP

60 mg / 2 mL (30 mg / mL), 2 mL fill in a 2 mL amber vial

NDC #63323-162-02

Product Code 160202

Batch Numbers: 6119229, 6119273, 6119843, 6121115, 6121451, 6121452, 6121496

The checks and balances that go into monitoring drug quality and the resulting drug recalls are an important part of the process of keeping corporations accountable for the drugs they manufacture and sell. Drug recalls are published regularly on RxWatch as part of our public service in keeping people safe, and in ensuring that consumers can trust their medications and medical implants.

If you or a loved one was administered Ketorolac Tromethamine injection between May 30, 2018 and April 20, 2020 and experienced inflamed and infected tissues, blood clots traveling to the lung, scarring of lung tissues, allergic reactions or other life-threatening consequences, contact the attorneys at 1-800-RxWatch for a free, no-obligation case review.

OnderLaw has a long history of forcing corporations to maintain and elevate their own safety standards so that the American public is safe from harm. If you or a loved one experienced injury or death due to a dangerous prescription or over-the-counter drug, or if a faulty medical device caused damage or death, contact OnderLaw at 1-800-RXWatch.

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