Recall Issued for Ketorolac Tromethamine

WASHINGTON, D.C. — The U.S. Food and Drug Administration, or FDA, announced a recall of an injectable nonsteroidal, anti-inflammatory drug (NSAID) over concerns that the injection could lead to a blood infection. The FDA formally announced the recall on May 1, 2019, according to Orthopedics This Week. The FDA identified the product as Ketorolac Tromethaminemanufactured by Sargent Pharmaceuticals. Sargent Pharmaceuticals distributed the affected lot between January and March 2019. The company warned that patients who have an injection with the tainted medicine could fall into septic shock and ultimately die after suffering a blood infection, and the company voluntarily recalled the product.

Sargent Pharmaceuticals recalled the Ketorolac Tromethamine, USP, 60mg/2ml (30mg per ml) injections after discovering that microbes grew during a simulated manufacturing process of the medication. Accordingly, the FDA announced that evidence of bacteria growth during the simulated manufacturing process could result in the growth of micro-organisms during the manufacturing process of medicine to be distributed. Any adult who received the tainted drugs could develop sepsis.

The FDA warned patients and physicians to carefully examine their inventory to determine whether they have a tainted lot of medication. Sargent Pharmaceuticals reported that the lot in question is M813513, dated February 2020, NDC number 25021-701-02 and was manufactured for Sargent Pharmaceuticals by Zydus (Cadila Healthcare Limited). The FDA warned wholesale distributors of the drug such as hospitals to contact anyone who might have come in contact with the drug and advise that they discontinue using the medicine and return it immediately. Sargent Pharmaceuticals asked customers to visit their website to download the necessary documentation to include with the recalled product. Any person who develops an illness after taking the injection must contact their doctor immediately.

Healthcare providers prescribe Ketorolac Tromethamine to combat severe pain on a short-term basis of approximately five days. Physicians prescribe Ketorolac Tromethamine as an alternative for prescribing an opioid narcotic.

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