fdaMay 05, 2019
Tag: recall , Sagent Pharmaceuticals , Sterility Assurance
Company Announcement Date:April 30, 2019
FDA Publish Date:May 03, 2019
Product Type:Drugs
Reason for Announcement:Device & Drug Safety, Potential Lack of Sterility
Company Name:Sagent Pharmaceuticals
Brand Name:Sagent Pharmaceuticals
Product Description:Ketorolac Tromethamine Injection
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.
Adult patients administered the product intravenously are at most risk of a serious bloodstream infection of sepsis (serious condition resulting from the presence of harmful microorganisms in the blood and the body’s response to their presence, potentially leading to shock and death). The possibility of a breach in sterility assurance in distributed product, while remote, cannot be eliminated. No batches of distributed product have been identified as actually containing microorganisms. To date, Sagent has not received reports of any adverse events associated with this issue.
Ketorolac Tromethamine Injection, USP, is a nonsteroidal anti-inflammatory drug (NSAID), is indicated for the short-term (up to 5 days in adults), management of moderately severe acute pain that requires analgesia at the opioid level.
The product is supplied in 2 ml glass tubular vials. The lot number being recalled was distributed to hospitals, wholesalers and distributors nationwide from January – March 2019.
Product | Lot Number | Expiration Date | NDC Number | Distribution Dates |
---|---|---|---|---|
Ketorolac Tromethamine Injection, USP, 60mg per 2mL (30mg per 1mL) | M813513 | Feb-2020 | 25021-701-02 | January – March 2019 |
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