SwastiChemEx: Sagent Pharma recalls - ketorolac tromethamine inj due to incorrect labels

Tuesday, 7 October 2014

Sagent Pharma recalls - ketorolac tromethamine inj due to incorrect labels

Sagent Pharmaceuticals, a specialty pharmaceutical company focused on developing, manufacturing, sourcing and marketing pharmaceutical products, announced the 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 labelling the product with the incorrect expiration date. The labelled 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.

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