The Recall Desk
HighFDA (Drugs)·D-0483-2015·Announced 2015-04-15

Hospira Recalls Ketorolac Tromethamine Injections Due to Crystallization

Hospira Inc. is voluntarily recalling specific lots of Ketorolac Tromethamine Injection due to crystallization. The recall covers vials distributed nationwide and internationally.

What this means for you

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 FDA classified this as a Class II recall, and crystallization in an injectable medication presents a risk of harm where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Hospira Inc. is voluntarily recalling specific lots of Ketorolac Tromethamine Injection, USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials. The recall was initiated because of crystallization in the product. The affected product is labeled under NDC 0409-3796-01 and also under the NOVAPLUS label NDC 0409-3796-49.

The recall involves 4,339,500 vials under the Hospira label and 341,100 vials under the Novaplus label. The affected lots have expiration dates ranging from February 2015 to October 2016. Specific lot numbers include 26-098-DK, 29-239-DK, 29-240-DK, 34-540-DK, 37-037-DK, 37-038-DK, 37-147-DK, 37-148-DK, 37-228-DK, 37-282-DK, 41-282-DK, 41-284-DK, 44-076-DK, 45-240-DK, 46-306-DK, and 26-097-DK.

The product was distributed throughout the United States and internationally to Guam and Singapore. The FDA has classified this recall as Class II, which means there is a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed and stop using the affected product.

The recalled product

Product
KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
Brand
KETOROLAC TROMETHAMINE
Manufacturer
Hospira Inc.
Category
Drug — Injectable Medication
Hazard

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 (20)

  • NDC 0409-3796-01
  • Lot number: 26-098-DK
  • Exp. Date:1FEB2015
  • Lot number: 29-239-DK
  • 29-240-DK
  • Exp. Date:1MAY2015
  • Lot number: 34-540-DK
  • Exp. Date:1OCT2015
  • Lot number: 37-037-DK
  • 37-038-DK
  • 37-147-DK
  • 37-148-DK
  • 37-228-DK
  • 37-282-DK
  • Exp. Date:1JAN2016
  • Lot number: 41-282-DK
  • 41-284-DK
  • Exp. Date:1MAY2016
  • Lot number: 44-076-DK
  • Exp. Date:1AUG2016

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Related recalls

Same brand · KETOROLAC TROMETHAMINE

Same manufacturer · Hospira Inc.

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Same hazard · crystallization

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