The Recall Desk
SevereFDA (Drugs)·D-0973-2015·Announced 2015-05-06

Hospira Recalls Ketorolac Tromethamine Injections Due to Crystallization

Hospira is voluntarily recalling specific lots of Ketorolac Tromethamine Injections because of crystallization. The affected products were distributed nationwide, in Puerto Rico, and in Guam.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score according to the rubric.

Plain-English summary

Hospira Inc. is voluntarily recalling specific lots of Ketorolac Tromethamine Inj. USP, 60 mg (30 mg/mL), 2 mL Fill, Single-dose vials. The recall was initiated because the product experienced crystallization. The affected lots are identified by specific lot numbers and expiration dates, including those labeled under the NOVAPLUS brand.

The affected products were distributed nationwide, as well as in Puerto Rico and Guam. The recall was initiated by the firm and classified as Class II by the FDA. The recall status is currently terminated.

Healthcare providers and patients should stop using the affected lots of Ketorolac Tromethamine Injections. Consumers should check their medication vials for the specific lot numbers and expiration dates listed in the recall notice. If the medication matches the recalled lots, it should be returned to the pharmacy or healthcare provider for disposal or replacement.

The recalled product

Product
Ketorolac Tromethamine Inj. USP, 60 mg (30 mg/mL), 2 mL Fill, Single-dose vial, Rx Only, Hospira Inc., Lake Forest, IL --- NDC 00409-3796-01 --- Also labeled under NOVAPLUS label NDC 00409-3796-49
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 (6)

  • Lot 38-135-DK
  • 38-136-DK Exp. Date 1FEB2016
  • Lots 44-075-DK
  • 44-356-DK Exp. Date 1AUG2016
  • Lots 44-357-DK
  • 44-358-DK Exp. Date 1AUG2016

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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