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Sagent recalls three lots of Ketorolac Tromethamine Injection, USP, 30mg/ml

Sagent Pharmaceuticals has recalled 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 and distributed by Sagent.

The company has started this voluntary recall to the user level due to labeling the product with the incorrect expiration date, which is longer than the known stability of the product.

So far, the company is not aware of any adverse patient events resulting from the use of Ketorolac Tromethamine Injection, USP, 30mg/ml, a nonsteroidal anti-inflammatory drug (NSAID).

The recalled products are MP5021, MP5024 and MP5025, which were distributed to hospitals, wholesalers and distributors nationwide from 17 September 2014 through 01 October 2014.

The drug is 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 company is notifying customers by fax, email, FedEx, and/or certified mail that includes arrangements for return of all recalled product.

Customers have been asked to examine their inventory immediately and to quarantine, discontinue distribution of and return the recalled lots of the product.