The Recall Desk
HighFDA (Drugs)·D-0482-2015·Announced 2015-04-15

Hospira Recalls Ketorolac Tromethamine Injection Due to Crystallization

Hospira Inc. is voluntarily recalling specific lots of Ketorolac Tromethamine Injection because of crystallization. The affected vials were distributed nationwide and in Guam and Singapore.

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. Per the rubric, a Class II recall without explicit reports of hospitalization or death corresponds to a High severity score (3), representing a risk of temporary or medically reversible adverse health consequences.

Plain-English summary

Hospira Inc. is voluntarily recalling specific lots of KETOROLAC Tromethamine Injection, USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, intended for intravenous (I.V.) or intramuscular (I.M.) use. The recall was initiated on January 23, 2015, due to the presence of crystallization in the product. The affected product is identified by NDC 0409-3795-01 and NDC 0409-3795-49 (Novaplus label).

The recall covers a total of 15,248,975 vials, consisting of 13,720,475 vials under the Hospira label and 1,528,500 vials under the Novaplus label. The affected lots have expiration dates ranging from January 2015 to October 2016. Specific lot numbers include 25-047-DK, 25-048-DK, 26-151-DK, 28-059-DK, 28-071-DK, 28-072-DK, 28-479-DK, 28-480-DK, 29-556-DK, 29-557-DK, 35-232-DK, 35-233-DK, 35-234-DK, 35-501-DK, 36-341-DK, 36-342-DK, 36-343-DK, 36-353-DK, 36-429-DK, 36-430-DK, 37-141-DK, 37-142-DK, 37-144-DK, 37-145-DK, 37-353-DK, 38-141-DK, 38-143-DK, 39-014-DK, 39-104-DK, 40-301-DK, 40-536-DK, 40-537-DK, 40-544-DK, 40-548-DK, 41-078-DK, 42-207-DK, 42-253-DK, 45-358-DK, 45-359-DK, 46-043-DK, 46-044-DK, 46-047-DK, 27-101-DK, 35-229-DK, 36-217-DK, 36-218-DK, and 40-534-DK.

The affected product was distributed throughout the United States and internationally to Guam and Singapore. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The recall was initiated by the firm and was terminated on February 4, 2016.

The recalled product

Product
KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
Brand
KETOROLAC TROMETHAMINE
Manufacturer
Hospira Inc.
Category
Drug — Injection
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 0409-3795-01
  • Lot number: 25-047-DK
  • 25-048-DK
  • Exp 1JAN2015
  • Lot number 26-151-DK
  • Exp. Date:1FEB2015
  • Lot number: 28-059-DK
  • 28-071-DK
  • 28-072-DK
  • 28-479-DK
  • 28-480-DK
  • Exp. Date:1APR2015
  • Lot number: 29-556-DK
  • 29-557-DK
  • Exp. Date:1MAY2015
  • Lot number: 35-232-DK
  • 35-233-DK
  • 35-234-DK
  • 35-501-DK
  • Exp. Date:1NOV2015

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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