Patients in and around Indiana should be aware of allegedly defective ketorolac tromethamine injections distributed by Sagent Pharmaceuticals.
On April 30th, the company announced a voluntary, nationwide recall of it’s 60mg/2mL injections after discovering microbial growth during what has been described as a “routine simulation of the manufacturing process.”
Ketorolac Tromethamine Injections Used for Pain Management
Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug (NSAID) used for pain management in adults. Administered via injection, it is designed for short-term, analgesic use and helps patients manage moderately severe acute pain that requires relief at the opioid level.
The 2mL vials were distributed to hospitals, wholesalers, and private practitioners across the United States from January to March of 2019. All customers, distributors, and retailers have been advised to stop using the product and return it to the manufacturer.
The defective drug may have been distributed in Indianapolis and the surrounding areas. Patients who were administered the drug intravenously are most at-risk of contracting sepsis. This is a serious, potentially life-threatening infection in the bloodstream that can lead to shock and/or death.
About the Sagent / Zydus Recall
Sagent voluntarily recalled the drug in April of 2019 after discovering microbial growth in Lot #M813513 of the injections. The product was manufactured in India by Zydus (Cadila Healthcare Lumuted).
What You Can Do if You’ve Been Affected
If you were treated for pain in the hospital, clinic, or other medical facility from January to March of 2019, contact your provider and find out which injections you were given, along with the name of the distributor.
- Product: Ketorolack Tromethamine Injection, USP, 60mg per 2mL (30mg per 1 mL)
- Distributor: Sagent Pharmaceuticals, Inc.
- Lot #: M813513
- NDC #: 25021-701-02
- Expiration Date: Feb. 2020
If you’ve been treated with a ketorolac tromethamine injection, monitor your health closely. If you experience any symptoms of sepsis, seek immediate medical treatment. Signs and symptoms of sepsis include:
- Change in mental status
- High respiratory rate (22 or more breaths per minute)
- Blood pressure/systolic pressure less than or equal to 100 millimeters of mercury
In the event of an infection or other adverse reaction, report your symptoms to MedWatch immediately. Reports can be made online, or by phone at 1-800-332-1088.
Your infection may also be grounds for a medical malpractice lawsuit.