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
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA has classified this recall as Class I, which meets the rubric criteria for a Critical severity score.
Plain-English summary
Fresenius Kabi USA, LLC is recalling 5,314,400 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 distribution across the USA Nationwide and Puerto Rico.
The recall was initiated because particulate matter was found in reserve sample vials at the firm. The specific lots affected are 6118737, 6118902, 6119052, 6119752, 6122349, and 6122538, with expiration dates ranging from April 2020 to September 2021.
Healthcare providers and patients should stop using the affected lots of this medication. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.
The recalled product
- Product
- KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
- Brand
- KETOROLAC TROMETHAMINE
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Injection
- Hazard
- Affected units
- 5,314,400
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 #: 6118737
- 6118902
- Exp 04/2020
- 6119052
- Exp 05/2020
- 6119752
- Exp 08/2020
- 6122349
- Exp 07/2021
- 6122538
- Exp 09/2021
UPCs (4)
- 0363323162115
- 0363323161002
- 0363323162009
- 0363323162030
Distribution
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
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