Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0388-2015·Announced 2015-02-25

Hospira Recalls Ketorolac Tromethamine Injections Due to Temperature Abuse

Hospira Inc. is recalling 100 vials of Ketorolac Tromethamine Injection due to uncontrolled temperature excursions during transit. The product was limited to one shipment to a distributor.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation that could cause temporary or medically reversible adverse health consequences. The hazard is temperature abuse, which is a low-risk contamination or quality issue without reported illness.

Plain-English summary

Hospira Inc. is recalling 100 vials of Ketorolac Tromethamine Injection, USP, 60 mg (30 mg/mL), 2 mL Single-dose Fliptop Vial. The recall is due to temperature abuse, as the products experienced uncontrolled temperature excursions during transit.

The affected product is identified by Lot # 34-540-DK with an expiration date of 1OCT2015. The distribution was limited to one shipment to The Harvard Drug Group in Livonia, MI. These lots remained within the control of the distributor and were not further distributed.

Consumers and healthcare providers should check their inventory for this specific lot number. If found, the product should be returned to the distributor or the manufacturer for credit.

The recalled product

Product: KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
Brand: KETOROLAC TROMETHAMINE
Manufacturer: Hospira Inc.
Category: Drug — Injection
Hazard: temperature-abuse
Affected units: 100

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 (4)

One shipment of Lot #: 34-540-DK
Exp 1OCT2015 to The Harvard Drug Group
Livonia
MI

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Hospira Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same brand · KETOROLAC TROMETHAMINE

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Same manufacturer · Hospira Inc.

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Same hazard · temperature abuse