Policyholder Services

FDA Recall Alert: Sagent Pharmaceuticals Announces Voluntary Recall of Ketorolac Tromethamine Injection, USP, 30mg/mL Due to Incorrect Labeling

From Recent ASCRS Bulletin:

The Food and Drug Administration (FDA) alerted providers that Sagent Pharmaceuticals, Inc. is conducting a nationwide recall of three lots of Ketorolac Tromethamine Injection, USP, 30mg/mL, single-dose vial, manufactured by Cadila Healthcare Limited and distributed by Sagent.

The product was labeled with the incorrect expiration date.  The labeled expiration date is longer than the known stability of the product.

The lot numbers being recalled are MP5021, MP5024 and MP5025.  These lots were distributed to hospitals, wholesalers and distributors nationwide from September 17, 2014 through October 1, 2014.

Customers are advised to check inventory and to quarantine, discontinue distribution of and return the recalled lots of product. Customers who may have further distributed this product have been requested to identify their customers and notify them of this product recall.

Any questions about returning unused product should be directed to the customer call center at 866-625-1618, Monday through Friday, from 8am to 7pm CST.  Healthcare workers who have medical questions about Ketorolac Tromethamine Injection may contact Sagent Medical Affairs at 866-625-1618 and choose Option 3, Monday through Friday, 8am to 5pm CST.  Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by mail or by fax.

• Complete and submit the report online: www.fda.gov/medwatch/report.htm
• Mail or fax: download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

If you need additional information, please contact Ashley McGlone, manager of regulatory affairs, at amcglone@ascrs.org.