Sagent Pharmaceuticals Voluntarily Recalls Three Lots of Ketorolac Tromethamine for Labeling Error

Sagent Pharmaceuticals, Inc.has initiated  a voluntary nationwide recall of three lots 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. Sagent has initiated this voluntary recall of ketorolac tromethamine injection, USP, 30mg/mL to the user level due to labeling the product with the incorrect expiration date. The labeled expiration date is longer than the known stability of the product.

Sagent is not aware of any adverse patient events resulting from the use of this product.

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

Source: Sagent Pharmaceuticals 

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