Ketorolac Tromethamine Injection, USP, 30mg/ml by Sagent Pharmaceuticals: Recall - Incorrect Labeling

AUDIENCE: Pharmacy, Risk Manager, Nursing

ISSUE: Sagent Pharmaceuticals, Inc. issued a voluntary nationwide recall of three lots (lot numbers: MP5021, MP5024 and MP5025) of Ketorolac Tromethamine Injection, USP, 30mg/mL single-dose vials (NDC numbers 25021-701-01 and 25021-701-02) manufactured by Cadila Healthcare Limited and distributed by Sagent. The affected product was labeled with the incorrect expiration date. The labeled expiration date is longer than the known stability of the product.

BACKGROUND: Ketorolac Tromethamine Injection, USP, 30mg/mL is a nonsteroidal anti-inflammatory drug (NSAID) indicated for short-term management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting, and is supplied in a single-dose vial.

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

RECOMMENDATION: Customers have been instructed to examine their inventory immediately 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 at once of this product recall. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.  Any questions about returning unused product should be directed to the customer call center at (866) 625-1618 M-F 8am-7pm CST. Healthcare workers who have medical questions about Ketorolac Tromethamine Injection, USP may contact Sagent Medical Affairs (866-625-1618, Option 3) M-F 8am-5pm CST.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form 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

Read the MedWatch safety alert, including a link to the press release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm417445.htm