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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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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