Hospira Recalls 20 M Vials of Ketorolac
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Hospira has initiated a voluntary Class II recall of more than 20 million vials of ketorolac tromethamine injection, a non-steroidal anti-inflammatory drug, due to crystallization issues identified as a calcium salt of the drug. The recall was initiated on June 30, 2015 and applies nationwide in the United States (including Puerto Rico), Guam, Canada, and Singapore. The recall notice was reported in the US Food and Drug Administration’s Weekly Enforcement Report of July 22, 2015.

A Class II recall is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

The recall applies to Ketorolac (tromethamine injection) USP, in 60 mg (30 mg/mL), 2-mL single-dose vials IV/IM and 30 mg (30 mg/mL), 1-mL fill, single-use vials, IV/IM. The products were labeled were both the Hospira and Novaplus labels.

The specific amount of the recall is as follows: Ketorolac (tromethamine injection) USP, in 60 mg (30 mg/mL), 2-mL single-dose vials IV/IM, 5,124,900 vials (Hospira label) and 250,600 (Novaplus labels), and Ketorolac (tromethamine injection) US, 30 mg (30 mg/mL), 1-mL fill, single-use vials, 12,460,975 vials (Hospira label) and 3,016,500 (Novaplus labels). The total amount of vials recalled from both dosing levels and labels is 20, 942,975 vials.

Source: FDA (60 mg (30 mg/mL), 2-mL single-dose vials) and FDA (30 mg (30 mg/mL), 1-mL fill, single-use vials).

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