Agency classClass IIOur severity:High FDA (Drugs)·D-926-2013·Announced 2013-09-04

Hospira Recalls Ketorolac Tromethamine Injections Due to Sterility Concerns

Hospira, Inc. is recalling 345,800 vials of Ketorolac Tromethamine Injection due to a lack of assurance of sterility caused by loose or missing crimps on fliptop vials.

The agency’s classification

FDA (Drugs): Class II

Class II 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (infection) from a sterile product where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Hospira, Inc. is recalling 345,800 vials of Ketorolac Tromethamine Injection, USP, 30 mg. The recall involves Lot 25048DK with an expiration date of 01/15. The product is distributed nationwide.

The recall was initiated because there is a lack of assurance of sterility. Specifically, either a loose crimp or no crimp was applied to the fliptop vials, which compromises the integrity of the packaging.

Healthcare providers and patients should discontinue use of the affected vials. Consumers should check their medication for the specific lot number and expiration date listed above and contact their pharmacist or healthcare provider for guidance on replacement or disposal.

The recalled product

Product: KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
Brand: KETOROLAC TROMETHAMINE
Manufacturer: Hospira, Inc.
Category: Drug — Injection
Hazard: sterility
packaging-defect
Affected units: 345,800

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Lot 25048DK Exp. 01/15

Distribution

Distribution scope not specified by the agency.

Same brand · KETOROLAC TROMETHAMINE

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Same hazard · sterility