The Recall Desk
SevereFDA (Drugs)·D-1297-2020·Announced 2020-06-17

Fresenius Kabi Recalls Ketorolac Tromethamine Injection Due to Particulate Matter

Fresenius Kabi is recalling specific lots of Ketorolac Tromethamine Injection because particulate matter was found in reserve sample vials.

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 FDA classifies this as a Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving injectable medications where particulate matter poses a significant risk of adverse health consequences.

Plain-English summary

Fresenius Kabi USA, LLC is recalling specific lots of Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL). The product is packaged in 2 mL Single Dose Vials and is intended for intramuscular (IM) use only. The recall affects 3,497,575 vials distributed nationwide in the United States and Puerto Rico.

The recall was initiated because particulate matter was found in reserve sample vials at the firm. The affected lots are 6119229, 6119273, 6119843, 6121115, 6121451, 6121452, and 6121496, with expiration dates ranging from 06/2020 to 03/2021.

Healthcare providers and patients should stop using the affected lots and contact their healthcare provider or the manufacturer for further instructions. The FDA classifies this recall as Class II, indicating a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
Brand
KETOROLAC TROMETHAMINE
Manufacturer
Fresenius Kabi USA, LLC
Category
Drug — Injectable Prescription Drug
Hazard
Affected units
3,497,575

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 (11)

  • Lot #: 6119229
  • 6119273
  • Exp 06/2020
  • 6119843
  • Exp 09/2020
  • 6121115
  • Exp 02/2021
  • 6121451
  • 6121452
  • 6121496
  • Exp 03/2021

UPCs (4)

  • 0363323162115
  • 0363323161002
  • 0363323162009
  • 0363323162030

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Fresenius Kabi USA, LLC 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 · Fresenius Kabi USA, LLC

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Same hazard · particulate matter

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