Fresenius Kabi Recalls Ketorolac Tromethamine Injection Due to Particulate Matter
Fresenius Kabi is recalling specific vials of Ketorolac Tromethamine Injection because particulate matter was found in reserve samples.
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 agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
Fresenius Kabi USA, LLC is recalling 945,425 vials of Ketorolac Tromethamine Injection, USP, 30 mg per mL. The affected product is packaged in 1 mL Single Dose Vials and is intended for intramuscular or intravenous use. The recall covers Lot # 6121083, which has an expiration date of 2/2021.
The recall was initiated because particulate matter was found in reserve sample vials at the firm. The affected product was distributed nationwide in the United States and Puerto Rico.
Healthcare providers and patients should stop using the affected vials and contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
- Brand
- KETOROLAC TROMETHAMINE
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Injection
- Hazard
- Affected units
- 945,425
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 (2)
- Lot # 6121083
- Exp 2/2021
UPCs (4)
- 0363323162115
- 0363323161002
- 0363323162009
- 0363323162030
Distribution
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