The Recall Desk
ModerateFDA (Drugs)·D-0972-2015·Announced 2015-05-06

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 products distributed nationwide, in Puerto Rico, and in Guam.

What this means for you

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 and is a voluntary, firm-initiated action for crystallization. No illnesses, injuries, or deaths are reported in the source text, and the hazard is a physical defect rather than a high-risk pathogen or allergen.

Plain-English summary

Hospira Inc. has voluntarily initiated a recall of Ketorolac Tromethamine Inj. USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose vials. The recall is due to crystallization in the product. The affected products are prescription-only and are identified by NDC 00409-3795-01 and NDC 00409-3795-49 (NOVAPLUS label).

The recall includes specific lots with expiration dates ranging from November 2015 to October 2016. These products were distributed nationwide, as well as in Puerto Rico and Guam. The recall was initiated on April 13, 2015, and was classified as Class II by the FDA.

Healthcare providers and patients should stop using the affected lots and contact Hospira Inc. for further instructions. The recall status is currently terminated.

The recalled product

Product
Ketorolac Tromethamine Inj. USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose vial, Rx Only, Hospira Inc., Lake Forest, IL --- NDC 00409-3795-01--- Also labeled under NOVAPLUS label NDC 00409-3795-49
Manufacturer
Hospira Inc.
Category
Drug — Injectable
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 (19)

  • Lots 35-231-DK
  • 35-235-DK
  • 35-507-DK Exp. Date 1NOV2015
  • Lot 36-136-DK Exp. Date 1DEC2015
  • Lot 37-146-DK Exp. Date 1JAN2016
  • Lot 38-138-DK Exp. Date 1FEB2016
  • Lots 39-103-DK
  • 39-255-DK Exp. Date 1MAR2016
  • Lots 40-539-DK
  • 40-549-DK
  • Exp. Date 1APR2016
  • Lot 41-079-DK Exp. Date 1MAY2016
  • Lots 42-252-DK
  • 42-254-DK Exp. Date 1JUN2016
  • Lots 43-262-DK
  • 43-263-DK Exp. Date 1JUL2016
  • Lots 45-031-DK
  • 45-032-DK
  • 45-033-DK Exp. Date 1SEP2016

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

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 manufacturer · Hospira Inc.

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Same hazard · crystallization

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