Recall: Sagent Pharmaceuticals Ketorolac Tromethamine Injection
On 2019-04-30, the FDA announced that Sagent Pharmaceuticals is conducting a recall on Ketorolac Tromethamine Injection due to a possible . The recalled products were sold under the brand name(s) Sagent Pharmaceuticals during an unspecified time period throughout the regions shown in the map below.
In recent months, there have been 2 drugs recalls due to potential lack of sterility, including enroflox 100 injection, noromectin injection, ivermax 1% injection, eye drops and more. Additionally, there have been 27 drug and medical device recalls due to other health hazards as well as 77 food recalls.
Company Contact Information:
Name: Sagent Pharmaceuticals
Phone: (866) 625-1618
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Detailed Recall Information
Regions Where Sold: Nationwide
Product Description: Ketorolac Tromethamine Injection
Brand Name(s): Sagent Pharmaceuticals
Reason for Recall: Lack of Sterility
Official Recall Date: 2019-04-30
Additional information provided by the FDA.gov:
Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of one lot of Ketorolac Tromethamine Injection, USP, 60mg/2mL (30mg per mL). This product was manufactured by Zydus (Cadila Healthcare Limited) and distributed by Sagent Pharmaceuticals, Inc. Sagent has initiated this voluntary recall of Ketorolac Tromethamine Injection, USP to the to the user level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products. Read More.
More information may be available at FDA.gov
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Sources may include Food & Drug Administration (FDA), United States Department of Agriculture (USDA), Health Canada and companies involved with this or a related recall.