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Fresenius Kabi Issues Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP Due to the Presence of Particulate Matter


Press release content from Business Wire. The AP news staff was not involved in its creation.
Fresenius Kabi Issues Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP Due to the Presence of Particulate Matter
January 8, 2021 GMT
LAKE ZURICH, Ill. (BUSINESS WIRE) Jan 8, 2021
Fresenius Kabi USA is voluntarily recalling a single lot of Ketorolac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill in a 2 mL amber vial to the user level due to the presence of particulate matter. Particulate matter was found in reserve sample vials. No adverse event reports have been received for the recalled lot, which was produced and sold in 2019. ....

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Nephron Announces FDA Approval of Ketorolac, Signaling New Phase of Growth


Nephron Announces FDA Approval of Ketorolac, Signaling New Phase of Growth
Kennedy: Company Excited to Expand Generic Portfolio to Include Non-Respiratory Products
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WEST COLUMBIA, S.C., Dec. 22, 2020 /PRNewswire/  Nephron Pharmaceuticals Corporation is celebrating another milestone.
The company today announced Food and Drug Administration (FDA) approval of the Nephron Abbreviated New Drug Application (ANDA) for Ketorolac Tromethamine Injection USP, 60 mg/2 mL (30 mg/mL) in Single-Dose Vials. The vials are made of polypropylene plastic with a luer lock interface for needle-free dosing and are manufactured using Blow-Fill-Seal (BFS) technology. 
Ketorolac Tromethamine becomes one of the first ANDA-approved non-respiratory generic medications produced by Nephron, signaling a new phase of company growth. Nephron secured FDA approval for Sodium Chloride IV Bags earlier this year. ....

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